- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07605065
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Beenish Saquib Beenish Saquib, FCPS
- 전화번호: 0320-8519818
- 이메일: Beenishsaquib2018@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Reduction in Pain Score by ≥50% on Visual Analogue Scale
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 약물의 생리적 효과
- 항염증제
- 말초신경계 작용제
- 항류마티스제
- 감각 시스템 에이전트
- 진통제, 비마약성
- 진통제
- 유기 화학 물질
- 약리학 적 행동
- 화학 작용 및 용도
- 치료 용도
- 탄화수소
- 탄화수소, 순환
- 카르 복실 산
- 하이드 록시 산
- 탄화수소, 방향족
- 다 환식 화합물
- Anilides
- 아미드
- 아닐린 화합물
- 아민
- 아세타 닐리 드
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- 스테로이드, 불소
- 페놀
- 벤젠 유도체
- Pregnadienetriols
- 산, 카르 보 사이 클릭
- 파라-아미노 벤조이트
- 아미노벤조테스
- 벤조테스
- 하이드 록시 벤조이트
- 페닐 에테르
- 벤자 아미드
- 클로로 벤 조테스
- 하이드 록시 벤조이트 에테르
- 덱사메타손
- 아세트아미노펜
- 메토클로프라미드
- 항염증제, 비스테로이드성
기타 연구 ID 번호
- PEMH-EM-2026-001
- ERC/29/26 (기타 식별자: Pak Emirates Military Hospital Rawalpindi)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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