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- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Beenish Saquib Beenish Saquib, FCPS
- Número de telefone: 0320-8519818
- E-mail: Beenishsaquib2018@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Comparador Ativo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Reduction in Pain Score by ≥50% on Visual Analogue Scale
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Efeitos fisiológicos das drogas
- Agentes Antiinflamatórios
- Agentes do Sistema Nervoso Periférico
- Agentes Antirreumáticos
- Agentes do Sistema Sensorial
- Analgésicos Não Narcóticos
- Analgésicos
- Produtos químicos orgânicos
- Ações farmacológicas
- Ações e usos químicos
- Usos terapêuticos
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Ácidos carboxílicos
- Ácidos hidroxi
- Hidrocarbonetos, aromáticos
- Compostos policíclicos
- Anilides
- Amidas
- Compostos de anilina
- Aminas
- Acetanilidas
- Pregada
- Pregnas
- Esteróides
- Compostos de anel fundido
- Esteróides, fluorados
- Fenóis
- Derivados de benzeno
- Pregadienetriols
- Ácidos, carbocíclicos
- para-aminobenzóatos
- Aminobenzoates
- Benzoates
- Hidroxibenzoatos
- Éteres fenil
- Benzamides
- Clorobenzoatos
- Éteres de hidroxibenzoato
- Dexametasona
- Paracetamol
- Metoclopramida
- Agentes Antiinflamatórios Não Esteroidais
Outros números de identificação do estudo
- PEMH-EM-2026-001
- ERC/29/26 (Outro identificador: Pak Emirates Military Hospital Rawalpindi)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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