Dexamethasone Plus Metoclopramide Versus Paracetamol/NSAIDs for Primary Headache (DMPH)
Comparison of Efficacy of Combination Dexamethasone With Metoclopramide Versus Paracetamol/NSAIDs for Treatment of Primary Headache in ED at Tertiary Care Hospital: A Randomized Controlled Trial
Primary headache disorders are among the most common neurological conditions presenting to emergency departments and can significantly impair quality of life and daily functioning. Various medications are used for acute headache treatment, including paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), metoclopramide, and corticosteroids.
This randomized controlled trial aims to compare the efficacy of intravenous dexamethasone combined with metoclopramide versus intravenous paracetamol/NSAIDs in patients presenting with primary headache to the emergency department of Pak Emirates Military Hospital, Rawalpindi.
A total of 94 patients aged 18 to 60 years with clinically diagnosed primary headache will be enrolled and randomized into two groups. Group A will receive intravenous dexamethasone 8 mg plus intravenous metoclopramide 10 mg, while Group B will receive intravenous paracetamol or NSAIDs according to departmental protocol. Pain severity will be assessed using the Visual Analogue Scale (VAS) before treatment and again after 60 minutes. Treatment efficacy will be defined as at least 50% reduction in pain score from baseline.
The results of this study may help identify a more effective treatment strategy for acute primary headache management in emergency departments.
研究概览
详细说明
Primary headache disorders, particularly migraine and tension-type headache, are common causes of emergency department visits worldwide. Acute headache episodes can lead to substantial morbidity, decreased functional capacity, and increased healthcare utilization. Rapid and effective pain control is therefore essential in emergency settings.
Conventional treatment options for acute primary headache include paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs). Metoclopramide, a dopamine receptor antagonist, is frequently used because of its analgesic and antiemetic effects. Dexamethasone has demonstrated benefit in reducing headache recurrence and improving sustained symptom relief due to its anti-inflammatory properties.
Combination therapy using dexamethasone with metoclopramide may provide superior efficacy compared with standard analgesic therapy alone by targeting multiple pain pathways simultaneously. However, limited local evidence is available regarding the comparative effectiveness of these treatment approaches in patients presenting to emergency departments in Pakistan.
This randomized controlled trial will be conducted at the Department of Emergency Medicine, Pak Emirates Military Hospital, Rawalpindi. A total of 94 patients fulfilling eligibility criteria will be enrolled through non-probability consecutive sampling and randomized equally into two treatment groups.
Group A will receive intravenous dexamethasone 8 mg plus intravenous metoclopramide 10 mg. Group B will receive intravenous paracetamol 1 g or intravenous NSAIDs according to departmental protocol.
Baseline demographic and clinical information including age, gender, headache duration, headache type, and baseline Visual Analogue Scale (VAS) score will be recorded. Pain severity will be reassessed 60 minutes after treatment administration. The primary outcome measure will be efficacy, defined as at least 50% reduction in VAS pain score from baseline.
Data will be analyzed using SPSS version 26. The findings of this study may contribute to evidence-based management of acute primary headache in emergency departments and improve patient outcomes.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Beenish Saquib Beenish Saquib, FCPS
- 电话号码:0320-8519818
- 邮箱:Beenishsaquib2018@gmail.com
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Patients aged 18 to 60 years.
- Patients presenting with primary headache diagnosed clinically.
- Patients presenting within 72 hours of onset of headache.
- Patients with Visual Analogue Scale (VAS) pain score ≥5.
Exclusion Criteria:
- Patients with secondary headache disorders.
- Patients with known allergy to dexamethasone, metoclopramide, paracetamol, or NSAIDs.
- Pregnant females.
- Patients with hepatic impairment.
- Patients with renal impairment.
- Patients with peptic ulcer disease or gastrointestinal bleeding.
- Patients with extrapyramidal disorders.
- Patients already receiving corticosteroids within previous 48 hours.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Dexamethasone Plus Metoclopramide
Participants in this arm will receive intravenous dexamethasone 8 mg combined with intravenous metoclopramide 10 mg for treatment of primary headache in the emergency department
|
Participants will receive intravenous dexamethasone 8 mg in combination with intravenous metoclopramide 10 mg for treatment of primary headache in the emergency department.
|
|
有源比较器:Paracetamol/NSAIDs
Participants in this arm will receive intravenous paracetamol 1 g or intravenous NSAIDs according to departmental protocol for treatment of primary headache in the emergency department
|
Participants will receive intravenous paracetamol 1 g or intravenous non-steroidal anti-inflammatory drugs according to departmental protocol for treatment of primary headache in the emergency department
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reduction in Pain Score by ≥50% on Visual Analogue Scale
大体时间:60 minutes after administration of study medication
|
Efficacy will be assessed by reduction in Visual Analogue Scale (VAS) pain score by at least 50% from baseline after administration of study medication
|
60 minutes after administration of study medication
|
合作者和调查者
出版物和有用的链接
一般刊物
- GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Ashina M, Katsarava Z, Do TP, Buse DC, Pozo-Rosich P, Ozge A, Krymchantowski AV, Lebedeva ER, Ravishankar K, Yu S, Sacco S, Ashina S, Younis S, Steiner TJ, Lipton RB. Migraine: epidemiology and systems of care. Lancet. 2021 Apr 17;397(10283):1485-1495. doi: 10.1016/S0140-6736(20)32160-7. Epub 2021 Mar 25.
- Herekar AA, Ahmad A, Uqaili UL, Ahmed B, Effendi J, Alvi SZ, Shahab MA, Javed U, Herekar AD, Khanani R, Steiner TJ. Primary headache disorders in the adult general population of Pakistan - a cross sectional nationwide prevalence survey. J Headache Pain. 2017 Dec;18(1):28. doi: 10.1186/s10194-017-0734-1. Epub 2017 Feb 23.
- 8. Friedman BW, Corbo J, Lipton RB, Bijur PE, Gallagher EJ. A trial of metoclopramide plus dexamethasone for acute migraine in the emergency department. Ann Emerg Med. 2020;75(4):458-466.
- Colman I, Friedman BW, Brown MD, Innes GD, Grafstein E, Roberts TE, Rowe BH. Parenteral dexamethasone for acute severe migraine headache: meta-analysis of randomised controlled trials for preventing recurrence. BMJ. 2008 Jun 14;336(7657):1359-61. doi: 10.1136/bmj.39566.806725.BE. Epub 2008 Jun 9.
- 6. Huang Q, Yu H, Zhang N, Wang Y. Efficacy of dexamethasone in acute migraine management. Headache. 2020;60(7):1347-1355.
- 5. Friedman BW, Irizarry E, Solorzano C, Cisewski D, Nassery A, Bijur PE, et al. Randomized study of intravenous metoclopramide for acute migraine. Neurology. 2021;96(17):e2220-e2230.
- 4. Orr SL, Aubé M, Becker WJ, Davenport WJ, Dilli E, Dodick D, et al. Canadian Headache Society systematic review of emergency department management of migraine. Can J Neurol Sci. 2021;48(3):314-325
- Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137. doi: 10.1186/s10194-020-01208-0. No abstract available.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PEMH-EM-2026-001
- ERC/29/26 (其他标识符:Pak Emirates Military Hospital Rawalpindi)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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