Primary Headache
Conditions
Keywords
Dexamethasone, Metoclopramide, Paracetamol, NSAIDs
Brief summary
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.
Detailed description
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.
Interventions
Participants will receive intravenous dexamethasone 8 mg in combination with intravenous metoclopramide 10 mg 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
Sponsors
Study design
Masking description
This is an open-label study. No participants, care providers, investigators, or outcome assessors will be masked to treatment allocation
Intervention model description
Participants will be randomized into two parallel 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. Outcomes will be compared between groups after 60 minutes of treatment administration
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Pain Score by ≥50% on Visual Analogue Scale | 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 |