Dexamethasone Plus Metoclopramide Versus Paracetamol/NSAIDs for Primary Headache

NCT07605065 | Not Yet Recruiting Phase 4

• 2 other identifiers: PEMH-EM-2026-001ERC/29/26
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Headache

Keywords

Dexamethasone; Metoclopramide; Paracetamol; NSAIDs

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain Score by ≥50% on Visual Analogue Scale

  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

Study Arms (2)

Dexamethasone Plus Metoclopramide

EXPERIMENTAL

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

Drug: Dexamethasone Plus Metoclopramide

Paracetamol/NSAIDs

ACTIVE COMPARATOR

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

Drug: Paracetamol/NSAIDs

Interventions

Dexamethasone Plus Metoclopramide DRUG

Participants will receive intravenous dexamethasone 8 mg in combination with intravenous metoclopramide 10 mg for treatment of primary headache in the emergency department.

Dexamethasone Plus Metoclopramide

Paracetamol/NSAIDs DRUG

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

Paracetamol/NSAIDs

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Related Publications (9)

• 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.

  PMID: 33773613 RESULT

• 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.

  PMID: 28229320 RESULT

• 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.

  RESULT

• 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.

  PMID: 18541610 RESULT

• 6. Huang Q, Yu H, Zhang N, Wang Y. Efficacy of dexamethasone in acute migraine management. Headache. 2020;60(7):1347-1355.

  RESULT

• 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.

  RESULT

• 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

  RESULT

• 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.

  PMID: 33267788 RESULT

• 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.

  PMID: 34487721 RESULT

MeSH Terms

Interventions

Dexamethasone; Metoclopramide; Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Acetanilides; Anilides; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Central Study Contacts

Beenish Saquib Beenish Saquib, FCPS

CONTACT

0320-8519818; Beenishsaquib2018@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No participants, care providers, investigators, or outcome assessors will be masked to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident

Model Details: 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

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share