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Doganay Ozyilmaz O, Bayburt KA, Alkan A, Uysal H. Effects of Combined Antiemetic Protocol for the Prevention of Postoperative Nausea and Vomiting in Orthognathic Surgery: A Randomized Double Blinded Clinical Study. J Oral Maxillofac Surg 2025; 83:429-438. [PMID: 39824505 DOI: 10.1016/j.joms.2024.12.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2024] [Revised: 12/10/2024] [Accepted: 12/22/2024] [Indexed: 01/20/2025]
Abstract
BACKGROUND Postoperative nausea and vomiting (PONV) after orthognathic surgery remains one of the most common side effects despite the use of several medications. PURPOSE The study aimed to compare the frequencies of PONV between a combination of metoclopramide with granisetron and granisetron alone. STUDY DESIGN, SETTING, SAMPLE A randomized double-blind clinical trial was conducted in 66 consecutive patients who underwent orthognathic surgery at the Department of Oral and Maxillofacial Surgery at Bezmialem Vakif University. Patients with contraindications such as hypersensitivity to medications, gastrointestinal or metabolic disorders, renal insufficiency, electrolyte imbalances, pregnancy, neurological diseases, prolonged QT interval, or mental retardation were excluded. PREDICTOR VARIABLE The predictor variable was the antiemetic treatment (combination vs single therapy). Participants were randomized to either the metoclopramide with granisetron group (group GM) or the granisetron-only group (group G). MAIN OUTCOME VARIABLE The outcome variable was PONV status, measured using the simplified postoperative nausea and vomiting impact scale. The participants were assessed at baseline (when fully awake) and during the subsequent 24 hours. COVARIATES Patient characteristics, total drug doses, systolic and diastolic blood pressure, peripheral arterial oxygen saturation, Apfel's PONV risk score, total bleeding volume, infused fluid volume, surgery duration, PONV incidence, visual analog scale scores, tramadol requirement, and the use of rescue antiemetics were determined as covariates. ANALYSES Data were analyzed using the Mann-Whitney U test with P value less than.05 considered significant. RESULTS The sample consisted of 60 participants, with 30 patients in each treatment group. The mean age was 30 ± 11.6 years in group G and 25.63 ± 10 years in group GM (P = .1); 42% of participants were male (P = .8). PONV scores at the second hour were 1.56 ± 1.45 in group G and 0.79 ± 0.90 in group GM (P = .03). The difference between the groups was statistically significant (P < .001). Participants in group G had a 1.61-fold higher risk of vomiting than those in the group GM (Relative risk = 1.61; 95% CI, 1.313 to 1.962). CONCLUSION AND RELEVANCE Compared to granisetron alone, the combination of granisetron and metoclopramide was associated with significant PONV control in patients undergoing orthognathic surgery. A multimodal approach may be adopted to reduce the incidence of PONV in patients undergoing maxillofacial surgery.
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Affiliation(s)
- Ozge Doganay Ozyilmaz
- Associate Professor, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Bezmialem Vakıf University, Istanbul, Turkey.
| | - Kemal Atakan Bayburt
- Assistant Professor, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Biruni University, Cevizlibag/Istanbul, Turkey
| | - Alper Alkan
- Professor, Oral and Maxillofacial Surgery, Private Practice, Proimtech A.Ş., Istanbul, Turkey
| | - Harun Uysal
- Associate Professor, Department of Anesthesiology and Reanimation, Bezmialem Vakıf University, Istanbul, Turkey
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deSouza IS, Anthony N, Thode H, Allen R, Belyavskaya J, Koos J, Singer A. Effectiveness and Safety of Pharmacologic Therapies for Migraine in the Emergency Department: A Systematic Review and Bayesian Network Meta-analysis. Ann Emerg Med 2025; 85:313-329. [PMID: 39674934 DOI: 10.1016/j.annemergmed.2024.11.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2024] [Revised: 10/07/2024] [Accepted: 11/05/2024] [Indexed: 12/17/2024]
Abstract
STUDY OBJECTIVE We performed a systematic review and Bayesian network meta-analysis to determine which pharmacologic therapies are relatively more effective and safer for migraine in adult patients who present to the emergency department (ED). METHODS We searched MEDLINE, Embase, and Web of Science from inception to February 9, 2024. Eligible studies were randomized controlled trials that enrolled adult participants presenting to ED with migraine and compared one pharmacologic therapy to another or placebo. Outcomes were as follows: 1) adequate pain relief at 2 hours, 2) change in pain intensity at 1 hour, 3) need for rescue drug at 2 hours, and 4) significant adverse reaction. We extracted data according to PRISMA-network meta-analysis and appraised trials using Cochrane RoB 2. For dichotomous outcomes, we performed Bayesian network meta-analysis to calculate odds ratios with 95% credible intervals; for continuous outcomes, we performed frequentist network meta-analysis to calculate mean differences with 95% confidence intervals. We assessed confidence using Confidence in Network Meta-analysis. We used Surface under the cumulative ranking curve (SUCRA) to rank agents. RESULTS Chlorpromazine intravenous (IV)/intramuscular (IM) (SUCRA=87.3%) was most likely to be superior for "adequate pain relief at 2 hours" (24 trials; n=2,361); metoclopramide IV-ibuprofen IV (SUCRA=94.6%) was most likely to be superior for "need for rescue drug" (not needing rescue drug) at 2 hours (27 trials; n=2,942); dexamethasone IV (SUCRA=79.5%) was most likely to be superior for "significant adverse reaction" (not causing adverse reaction) (22 trials; n=2,450). The network for change in pain intensity demonstrated statistically significant incoherence at the overall level. Confidence in network meta-analysis estimates (certainty of evidence) varied and was mostly "low" or "very low," limiting the validity of the probabilistic analyses. CONCLUSIONS According to Bayesian network meta-analysis, ibuprofen IV is definitely among the least effective for adequate pain relief; chlorpromazine IV/IM is definitely among the most effective; valproate IV is definitely among the least effective, and ketorolac IV/IM is possibly among the least effective as single agents. The relative safety of the pharmacologic therapies cannot be determined with sufficient certainty.
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Affiliation(s)
- Ian S deSouza
- Department of Emergency Medicine, SUNY Downstate Health Sciences University and Kings County Hospital Center, Brooklyn, NY.
| | - Nicole Anthony
- Department of Emergency Medicine, New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY
| | - Henry Thode
- Emergency Medicine Research Center, Stony Brook University, Stony Brook, NY
| | - Robert Allen
- Department of Emergency Medicine, LA General Medical Center, Los Angeles, CA
| | - Jane Belyavskaya
- Department of Emergency Medicine, SUNY Downstate Health Sciences University and Kings County Hospital Center, Brooklyn, NY
| | - Jessica Koos
- Health Sciences Library, Stony Brook University, Stony Brook, NY
| | - Adam Singer
- Department of Emergency Medicine, Stony Brook University, Stony Brook, NY
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Kirkland SW, Visser L, Meyer J, Junqueira DR, Campbell S, Villa-Roel C, Friedman BW, Essel NO, Rowe BH. The effectiveness of parenteral agents for pain reduction in patients with migraine presenting to emergency settings: A systematic review and network analysis. Headache 2024; 64:424-447. [PMID: 38644702 DOI: 10.1111/head.14704] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/05/2023] [Revised: 01/16/2024] [Accepted: 01/29/2024] [Indexed: 04/23/2024]
Abstract
OBJECTIVES To assess the comparative effectiveness and safety of parenteral agents for pain reduction in patients with acute migraine. BACKGROUND Parenteral agents have been shown to be effective in treating acute migraine pain; however, the comparative effectiveness of different approaches is unclear. METHODS Nine electronic databases and gray literature sources were searched to identify randomized clinical trials assessing parenteral agents to treat acute migraine pain in emergency settings. Two independent reviewers completed study screening, data extraction, and Cochrane risk-of-bias assessment, with differences being resolved by adjudication. The protocol of the review was registered with the International Prospective Register of Systematic Reviews (PROSPERO; CRD42018100096). RESULTS A total of 97 unique studies were included, with most studies reporting a high or unclear risk of bias. Monotherapy, as well as combination therapy, successfully reduced pain scores prior to discharge. They also increased the proportion of patients reporting pain relief and being pain free. Across the pain outcomes assessed, combination therapy was one of the higher ranked approaches and provided robust improvements in pain outcomes, including lowering pain scores (mean difference -3.36, 95% confidence interval [CI] -4.64 to -2.08) and increasing the proportion of patients reporting pain relief (risk ratio [RR] 2.83, 95% CI 1.74-4.61). Neuroleptics and metoclopramide also ranked high in terms of the proportion of patients reporting pain relief (neuroleptics RR 2.76, 95% CI 2.12-3.60; metoclopramide RR 2.58, 95% CI 1.90-3.49) and being pain free before emergency department discharge (neuroleptics RR 4.8, 95% CI 3.61-6.49; metoclopramide RR 4.1, 95% CI 3.02-5.44). Most parenteral agents were associated with increased adverse events, particularly combination therapy and neuroleptics. CONCLUSIONS Various parenteral agents were found to provide effective pain relief. Considering the consistent improvements across various outcomes, combination therapy, as well as monotherapy of either metoclopramide or neuroleptics are recommended as first-line options for managing acute migraine pain. There are risks of adverse events, especially akathisia, following treatment with these agents. We recommend that a shared decision-making model be considered to effectively identify the best treatment option based on the patient's needs.
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Affiliation(s)
- Scott W Kirkland
- Department of Emergency Medicine, Faculty of Medicine & Dentistry, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
| | - Lloyd Visser
- Department of Emergency Medicine, Faculty of Medicine & Dentistry, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
| | - Jillian Meyer
- Department of Emergency Medicine, Faculty of Medicine & Dentistry, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
| | | | - Sandra Campbell
- Health Sciences Library, University of Alberta, Edmonton, Alberta, Canada
| | - Cristina Villa-Roel
- Department of Emergency Medicine, Faculty of Medicine & Dentistry, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
| | - Benjamin W Friedman
- Department of Emergency Medicine, Albert Einstein College of Medicine, New York, New York, USA
| | - Nana Owusu Essel
- Department of Emergency Medicine, Faculty of Medicine & Dentistry, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
| | - Brian H Rowe
- Department of Emergency Medicine, Faculty of Medicine & Dentistry, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
- School of Public Health, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
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Abdelmonem H, Abdelhay HM, Abdelwadoud GT, Alhosini ANM, Ahmed AE, Mohamed SW, Al-Dardery NM, Abd-ElGawad M, Kamel MA. The efficacy and safety of metoclopramide in relieving acute migraine attacks compared with other anti-migraine drugs: a systematic review and network meta-analysis of randomized controlled trials. BMC Neurol 2023; 23:221. [PMID: 37291500 DOI: 10.1186/s12883-023-03259-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2023] [Accepted: 05/25/2023] [Indexed: 06/10/2023] Open
Abstract
BACKGROUND Many drugs are prescribed in relieving acute migraine attacks, we aim to compare metoclopramide with other antimigraine drugs. METHODS We searched online databases like PubMed, Cochrane Library, Scopus, and Web of Science till June 2022 for RCTs that compared metoclopramide alone with placebo or active drugs. The main outcomes were the mean change in headache score and complete headache relief. The secondary outcomes were the rescue medications need, side effects, nausea and recurrence rate. We qualitatively reviewed the outcomes. Then, we performed the network meta-analyses (NMAs) when it was possible. which were done by the Frequentist method using the MetaInsight online software. RESULTS Sixteen studies were included with a total of 1934 patients: 826 received metoclopramide, 302 received placebo, and 806 received other active drugs. Metoclopramide was effective in reducing headache outcomes even for 24 h. The intravenous route was the most chosen route in the included studies and showed significant positive results regarding headache outcomes; however, the best route whether intramuscular, intravenous, or suppository was not compared in the previous studies. Also, both 10 and 20 mg doses of metoclopramide were effective in improving headache outcomes; however, there was no direct comparison between both doses and the 10 mg dose was the most frequently used dosage. In NMA of headache change after 30 min or 1 h, metoclopramide effect came after granisetron, ketorolac, chlorpromazine, and Dexketoprofen trometamol. Only granisetron's effect was significantly higher than metoclopramide's effect which was only significantly higher than placebo and sumatriptan. In headache-free symptoms, only prochlorperazine was non-significantly higher than metoclopramide which was higher than other medications and showed significantly higher effects only with placebo. In rescue medication, metoclopramide's effect was only non-significantly lower than prochlorperazine and chlorpromazine while its effect was higher than other drugs and showed higher significant effects only than placebo and valproate. In the recurrence rate, studies showed no significant difference between metoclopramide and other drugs. Metoclopramide significantly decreased nausea more than the placebo. Regarding side effects, metoclopramide showed a lower incidence of mild side effects than pethidine and chlorpromazine and showed a higher incidence of mild side effects than placebo, dexamethasone, and ketorolac. The reported extrapyramidal symptoms with metoclopramide were dystonia or akathisia. CONCLUSION A dose of 10 mg IV Metoclopramide was effective in relieving migraine attacks with minimal side effects. Compared to other active drugs, it only showed a lower significant effect compared with granisetron regarding headache change while it showed significantly higher effects only with placebo in both rescue medication needs and headache-free symptoms and valproate in only rescue medication need. Also, it significantly decreased headache scores more than placebo and sumatriptan. However, more studies are needed to support our results.
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Şafak S, Çorbacioğlu ŞK, Korucu O, Emektar E, Çevik Y. Comparison of ibuprofen and dexketoprofen in the management of migraine-related headache in the emergency department. Notf Rett Med 2022; 25:31-37. [DOI: 10.1007/s10049-022-01105-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/28/2022] [Indexed: 12/13/2022]
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Ungrungseesopon N, Wongtanasarasin W. Pain reduction and adverse effects of intravenous metoclopramide for acute migraine attack: A systematic review and meta-analysis of randomized-controlled trials. World J Methodol 2022; 12:319-330. [PMID: 36159095 PMCID: PMC9350726 DOI: 10.5662/wjm.v12.i4.319] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/04/2022] [Revised: 04/26/2022] [Accepted: 07/11/2022] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Metoclopramide may be used to treat people suffering from acute migraine. However, no comprehensive investigation on this issue has been recorded. This review will provide more solid evidence for the use of metoclopramide in treating acute migraine.
AIM To compare the efficacy of intravenous metoclopramide with other therapies in migraine attack treatment in an emergency department (ED).
METHODS We included randomized controlled trials of participants older than 18 years with acute migraine headaches, which included at least one arm that received intravenous (IV) metoclopramide at the ED. A literature search of PubMed, Web of Science, Cochrane Collaboration, and Reference Citation Analysis on December 31, 2021 retrieved other drugs or placebo-controlled studies without language limitation. The risk of bias was assessed using the Cochrane risk of bias tool. The primary endpoint was pain reduction at 60 min or closest to 1 h after treatment, as measured by the pain scale. Secondary endpoints included adverse effects or reactions resulting from metoclopramide or comparisons.
RESULTS Fourteen trials with a total of 1661 individuals were eligible for review. The risk of bias ranged from low to intermediate. IV metoclopramide administration was not associated with higher pain reduction at 1 h (Standard mean difference [SMD] = -0.03, 95% confidence interval [CI]: -0.33-0.28, P = 0.87). However, metoclopramide was associated with better pain reduction than placebo (SMD = 1.04, 95%CI: 0.50-1.58, P = 0.0002). In addition, side effects were not significantly different between IV metoclopramide and other drugs or placebo (odds ratio [OR] = 0.76, 95%CI: 0.48-1.19, P = 0.09 and OR = 0.92, 95%CI: 0.31-2.74, P = 0.54, respectively).
CONCLUSION Metoclopramide is more effective than placebo in treating migraine in the ED. Despite the observed tendency of decreased side effects, its effectiveness compared to other regimens is poorly understood. More research on this area is needed to treat migraine in acute care settings effectively.
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Affiliation(s)
- Nat Ungrungseesopon
- Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand
| | - Wachira Wongtanasarasin
- Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand
- Department of Emergency Medicine, UC Davis School of Medicine, Sacramento, CA 95817, USA
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Abiri S, Chegin M, Soleimani R, Hatami N, Kalani N, Rayatdoost E. Propofol + Granisetron vs. Propofol + Metoclopramide in Symptom Management of Acute Migraine Headache; a Double-Blind Randomized Clinical Trial. ARCHIVES OF ACADEMIC EMERGENCY MEDICINE 2022; 10:e19. [PMID: 35402989 PMCID: PMC8986497 DOI: 10.22037/aaem.v10i1.1561] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Introduction Acute headache is one of the most common reasons for emergency department (ED) visits. This study aimed to compare the combination of propofol and granisetron with propofol and metoclopramide in symptom management of acute migraine headache. Methods In this double-blind randomized clinical trial, 60 adult patients with acute migraine headache who referred to ED were randomly divided into two groups of propofol + metoclopramide and propofol + granisetron. Pain and nausea/vomiting severity as well as blood pressure were compared between groups 30, 45, and 60 minutes after treatment. Results The two groups had similar situation regarding mean age (p = 0.606), sex distribution (p = 0.793), baseline severity of pain (p = 0.642), frequency of nausea/vomiting (p = 0.488), and vital signs (p > 0.05). The severity of pain was similar in the two groups 30 (p = 0.731), 45 (p = 0.460), and 60 (p = 0.712) minutes after treatment. The number of patients with resistant nausea and vomiting 60 minutes after treatment was significantly higher in metoclopramide group (30.0% versus 10.0%; p = 0.033). Diastolic pressure 60 minutes after treatment (81.43 ±8.94 vs. 74.97 ± 4.8; p = 0.001) and heart rate 30 minutes after treatment (68.87 ±6.52 vs. 73.57± 7.62; p = 0.013) had statistically significant differences between the groups. Conclusion The combination of propofol and granisetron was superior to propofol and metoclopramide in case of controlling nausea and vomiting of cases with acute migraine headache; meanwhile, no differences were observed in case of pain relief and hemodynamic status between the two groups.
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Affiliation(s)
- Samaneh Abiri
- Department of Emergency Medicine, Research Center for Noncommunicable Diseases, Jahrom University of Medical Sciences, Jahrom, Iran
| | - Mehdi Chegin
- Department of Emergency Medicine, Research Center for Noncommunicable Diseases, Jahrom University of Medical Sciences, Jahrom, Iran
| | - Reza Soleimani
- Student Research Committee, Jahrom University of Medical Sciences, Jahrom, Iran
| | - Naser Hatami
- Student Research Committee, Jahrom University of Medical Sciences, Jahrom, Iran
| | - Navid Kalani
- Research Center for Social Determinants of Health, Jahrom University of Medical Sciences, Jahrom, Iran
| | - Esmail Rayatdoost
- Department of Emergency Medicine, Research Center for Noncommunicable Diseases, Jahrom University of Medical Sciences, Jahrom, Iran.,Corresponding author: Esmail Rayatdoost; Department of Emergency Medicine, Jahrom University of Medical Sciences, Jahrom, Iran. / Tel: 0098+9177396014
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Kazi F, Manyapu M, Fakherddine M, Mekuria K, Friedman BW. Second-line interventions for migraine in the emergency department: A narrative review. Headache 2021; 61:1467-1474. [PMID: 34806767 DOI: 10.1111/head.14239] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2021] [Revised: 10/15/2021] [Accepted: 10/17/2021] [Indexed: 11/28/2022]
Abstract
OBJECTIVE Millions of patients present to US emergency departments (ED) annually for the treatment of migraine. First-line treatments, including metoclopramide, prochlorperazine, and sumatriptan, fail to provide sufficient relief in up to one-third of treated patients. In this narrative review, we discuss the evidence supporting the use of injectable (intravenous, intramuscular, or subcutaneous) medications for patients in the ED who fail to improve sufficiently after treatment with first-line medication. METHODS We used the American Headache Society's guideline, "Management of Adults with Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies," published in 2016, to identify first-line medications for migraine. We then conducted a PubMed search to determine whether any evidence supported the use of these medications as second-line therapy and whether any evidence existed to support the use of injectable therapies not discussed in the guideline as second-line therapy. RESULTS We identified only scant high-quality randomized data of second-line therapy. Therefore, we based our recommendations on medications that have reliably demonstrated efficacy as first-line treatment of migraine. These medications include injectable non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen. Dihydroergotamine and valproic acid have some data supporting efficacy. More recently, greater occipital nerve blocks (GONBs) have been shown to be efficacious. With the exception of meperidine, opioids have been shown to be not efficacious. Most data published to date demonstrate no role for propofol and ketamine. CONCLUSIONS There are no evidence-based second-line treatments of migraine in the ED setting. For patients with migraine, who fail to improve after treatment with a first-line medication, it is reasonable to use an intravenous NSAID or intravenous acetaminophen. Alternatively, clinicians adept at performing a GONB may offer this treatment.
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Affiliation(s)
- Farnam Kazi
- Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA
| | - Mallika Manyapu
- Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA
| | - Maha Fakherddine
- Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA
| | - Kumelachew Mekuria
- Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA
| | - Benjamin W Friedman
- Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA
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VanderPluym JH, Halker Singh RB, Urtecho M, Morrow AS, Nayfeh T, Torres Roldan VD, Farah MH, Hasan B, Saadi S, Shah S, Abd-Rabu R, Daraz L, Prokop LJ, Murad MH, Wang Z. Acute Treatments for Episodic Migraine in Adults: A Systematic Review and Meta-analysis. JAMA 2021; 325:2357-2369. [PMID: 34128998 PMCID: PMC8207243 DOI: 10.1001/jama.2021.7939] [Citation(s) in RCA: 76] [Impact Index Per Article: 19.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
IMPORTANCE Migraine is common and can be associated with significant morbidity, and several treatment options exist for acute therapy. OBJECTIVE To evaluate the benefits and harms associated with acute treatments for episodic migraine in adults. DATA SOURCES Multiple databases from database inception to February 24, 2021. STUDY SELECTION Randomized clinical trials and systematic reviews that assessed effectiveness or harms of acute therapy for migraine attacks. DATA EXTRACTION AND SYNTHESIS Independent reviewers selected studies and extracted data. Meta-analysis was performed with the DerSimonian-Laird random-effects model with Hartung-Knapp-Sidik-Jonkman variance correction or by using a fixed-effect model based on the Mantel-Haenszel method if the number of studies was small. MAIN OUTCOMES AND MEASURES The main outcomes included pain freedom, pain relief, sustained pain freedom, sustained pain relief, and adverse events. The strength of evidence (SOE) was graded with the Agency for Healthcare Research and Quality Methods Guide for Effectiveness and Comparative Effectiveness Reviews. FINDINGS Evidence on triptans and nonsteroidal anti-inflammatory drugs was summarized from 15 systematic reviews. For other interventions, 115 randomized clinical trials with 28 803 patients were included. Compared with placebo, triptans and nonsteroidal anti-inflammatory drugs used individually were significantly associated with reduced pain at 2 hours and 1 day (moderate to high SOE) and increased risk of mild and transient adverse events. Compared with placebo, calcitonin gene-related peptide receptor antagonists (low to high SOE), lasmiditan (5-HT1F receptor agonist; high SOE), dihydroergotamine (moderate to high SOE), ergotamine plus caffeine (moderate SOE), acetaminophen (moderate SOE), antiemetics (low SOE), butorphanol (low SOE), and tramadol in combination with acetaminophen (low SOE) were significantly associated with pain reduction and increase in mild adverse events. The findings for opioids were based on low or insufficient SOE. Several nonpharmacologic treatments were significantly associated with improved pain, including remote electrical neuromodulation (moderate SOE), transcranial magnetic stimulation (low SOE), external trigeminal nerve stimulation (low SOE), and noninvasive vagus nerve stimulation (moderate SOE). No significant difference in adverse events was found between nonpharmacologic treatments and sham. CONCLUSIONS AND RELEVANCE There are several acute treatments for migraine, with varying strength of supporting evidence. Use of triptans, nonsteroidal anti-inflammatory drugs, acetaminophen, dihydroergotamine, calcitonin gene-related peptide antagonists, lasmiditan, and some nonpharmacologic treatments was associated with improved pain and function. The evidence for many other interventions, including opioids, was limited.
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Affiliation(s)
- Juliana H. VanderPluym
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Department of Neurology, Mayo Clinic, Scottsdale, Arizona
| | - Rashmi B. Halker Singh
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Department of Neurology, Mayo Clinic, Scottsdale, Arizona
| | - Meritxell Urtecho
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Allison S. Morrow
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Tarek Nayfeh
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Victor D. Torres Roldan
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Magdoleen H. Farah
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Bashar Hasan
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Samer Saadi
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Sahrish Shah
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Rami Abd-Rabu
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Lubna Daraz
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Larry J. Prokop
- Department of Library–Public Services, Mayo Clinic, Rochester, Minnesota
| | - Mohammad Hassan Murad
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
| | - Zhen Wang
- Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
- Division of Health Care Delivery Research, Mayo Clinic, Rochester, Minnesota
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Alpuente A, Tassorelli C, Diener HC, Silberstein SD, Pozo-Rosich P. Have the IHS Guidelines for controlled trials of acute treatment of migraine attacks been followed? Laying the ground for the 4th edition. Cephalalgia 2020; 40:778-787. [DOI: 10.1177/0333102420906843] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Background The International Headache Society (IHS) has published four editions of Guidelines for acute clinical trials in migraine in the past 28 years. This continuous update process has been driven by the increasing amount of scientific data in the field of migraine and by the need to continuously improve the quality of trials. Objectives To illustrate: i) the results of the analysis on the adherence of published trials to the 3rd edition published in 2012, in order to identify the critical areas that needed to be addressed in the 4th edition and ii) the changes introduced in this latter edition for improving adherence and methodology robustness. Methods We searched and reviewed all controlled trials on acute treatment of migraine published in the period 2012–2018 and we assessed their adherence to the 3rd edition of the IHS Guidelines using a score system based on the most important recommendations. Afterwards, we compared the two editions of the Guidelines and assessed the changes between them. Results We included data from 24 controlled clinical trials. Most trials had a randomized double-blind controlled (RDB) design, while a minority (16.7%) were non-randomized double-blind trials. Less than half (44.6%) of the RDB trials used the recommended “pain-free at 2 hours” endpoint as the primary efficacy measure. Trial design and evaluation of results were the areas that diverged the most from the recommendations. Conclusion Adherence to IHS guidelines for clinical trials has been suboptimal so far. The new edition has been adapted and optimized to facilitate uptake and strengthen the quality of evidence.
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Affiliation(s)
- Alicia Alpuente
- Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain
- Headache and Neurological Pain Research Group, VHIR, Universitat Autonoma of Barcelona, Barcelona, Spain
| | - Cristina Tassorelli
- Headache Science Center, IRCCS Mondino Foundation, Pavia, Italy
- Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy
| | | | - Stephen D Silberstein
- Department of Neurology, Thomas Jefferson University Hospital, Philadelphia, PA, USA
| | - Patricia Pozo-Rosich
- Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain
- Headache and Neurological Pain Research Group, VHIR, Universitat Autonoma of Barcelona, Barcelona, Spain
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Abstract
PURPOSE OF REVIEW The current article reviews recent data on treatment of acute headache patients in the acute care setting. RECENT FINDINGS Intravenous fluid hydration, a common component of emergency department (ED) migraine therapy, does not improve pain outcomes and leads to longer ED lengths of stay. Therefore, intravenous fluids should be administered only to migraine patients with clinical evidence of dehydration. Similarly, intravenous ketamine has garnered interest as a treatment for acute pain but does not provide substantial relief to migraine patients. New studies on the serotonin (5-HT3; 5-hydroxytryptamine-3) antagonist granisetron, intranasal lidocaine, and high-flow oxygen have reported conflicting results for migraine patients. Finally, although experts recommend avoiding opioids in migraine treatment, opioid administration remains prevalent in the ED. A new study has demonstrated that patients who receive intravenous hydromorphone in the ED are much less likely to attain acute headache relief. Standardized headache protocols may decrease opioid use and provide significant pain relief for patients. SUMMARY Recent data have clarified the role of opioids and ketamine in the ED (do not use!). The role of treatment protocols and intravenous fluids is still ill-defined. Subpopulations of migraine patients may benefit from high-flow oxygen and intranasal lidocaine.
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Korucu O, Dagar S, Çorbacioglu ŞK, Emektar E, Cevik Y. The effectiveness of greater occipital nerve blockade in treating acute migraine-related headaches in emergency departments. Acta Neurol Scand 2018; 138:212-218. [PMID: 29744871 DOI: 10.1111/ane.12952] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/17/2018] [Indexed: 01/03/2023]
Abstract
OBJECTIVE This study aimed to evaluate the effectiveness of a greater occipital nerve (GON) blockade against a placebo and classical treatments (non-steroidal anti-inflammatory drugs + metoclopramide) among patients who were admitted to the emergency department (ED) with acute migraine headaches. METHOD This prospective-randomized controlled study was conducted on patients with acute migraine headaches. The patients were randomly assigned to 3 treatment groups: the GON blockade group (nerve blockade with bupivacaine), the placebo group (injection of normal saline into the GON area), and the intravenous (IV) treatment group (IV dexketoprofen and metoclopramide). Sixty acute migraine attack patients were assigned to 3 groups of 20 patients each. The pain severity was assessed at 5, 15, 30, and 45 minutes with a 10-point pain scale score (PSS). RESULTS The mean decreases in the 5-, 15-, 30-, and 45-minutes PSS scores were greater in the GON blockade group than in the dexketoprofen and placebo groups. When comparing the 30- and 45-minutes PSS changes, a statistically significant difference was found among the 3 groups (P = .03 and P = .03, respectively). CONCLUSION A GON blockade was as effective as an IV dexketoprofen + metoclopramide treatment and superior to a placebo in patients with acute migraine headaches. Despite being an invasive procedure, a GON blockade might be an effective option for acute migraine treatment in the ED due to its rapid, easy, and safe application.
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Affiliation(s)
- O. Korucu
- Department of Neurology; University of Health Sciences; Kecioren Training and Research Hospital; Ankara Turkey
| | - S. Dagar
- Department of Emergency Medicine; University of Health Sciences; Kecioren Training and Research Hospital; Ankara Turkey
| | - Ş. K. Çorbacioglu
- Department of Emergency Medicine; University of Health Sciences; Kecioren Training and Research Hospital; Ankara Turkey
| | - E. Emektar
- Department of Emergency Medicine; University of Health Sciences; Kecioren Training and Research Hospital; Ankara Turkey
| | - Y. Cevik
- Department of Emergency Medicine; University of Health Sciences; Kecioren Training and Research Hospital; Ankara Turkey
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Craig S, Graudins A, Dalziel SR, Powell CVE, Babl FE. Review article: A primer for clinical researchers in the emergency department: Part VI. Measuring what matters: Core outcome sets in emergency medicine research. Emerg Med Australas 2018; 31:29-34. [DOI: 10.1111/1742-6723.12970] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2018] [Accepted: 02/18/2018] [Indexed: 12/14/2022]
Affiliation(s)
- Simon Craig
- Department of Medicine; Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University; Melbourne Victoria Australia
- Paediatric Emergency Department; Monash Medical Centre; Melbourne Victoria Australia
- Paediatric Research in Emergency Departments International Collaborative (PREDICT); Melbourne, Victoria Australia
- Emergency Research; Murdoch Children's Research Institute; Melbourne Victoria Australia
| | - Andis Graudins
- Department of Medicine; Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University; Melbourne Victoria Australia
- Paediatric Research in Emergency Departments International Collaborative (PREDICT); Melbourne, Victoria Australia
- Monash Emergency Service; Monash Health, Dandenong Hospital; Melbourne Victoria Australia
| | - Stuart R Dalziel
- Paediatric Research in Emergency Departments International Collaborative (PREDICT); Melbourne, Victoria Australia
- Children's Emergency Department; Starship Children's Hospital; Auckland New Zealand
- Liggins Institute; The University of Auckland; Auckland New Zealand
| | - Colin VE Powell
- Department of Child Health; Division of Population Medicine, School of Medicine, Cardiff University; Cardiff UK
- Department of Emergency Medicine, SIDRA Medical and Research Centre; Doha Qatar
| | - Franz E Babl
- Paediatric Research in Emergency Departments International Collaborative (PREDICT); Melbourne, Victoria Australia
- Emergency Research; Murdoch Children's Research Institute; Melbourne Victoria Australia
- Emergency Department; Royal Children's Hospital; Melbourne Victoria Australia
- The University of Melbourne; Melbourne, Victoria Australia
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