Primary HeadachePhase 4DMPHNCT07605065
Dexamethasone Plus Metoclopramide Versus Paracetamol/NSAIDs for Primary Headache
A Phase 4 study testing Dexamethasone Plus Metoclopramide and Paracetamol/NSAIDs in people with Primary Headache, run by Pak Emirates Military Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Headache
- What is being tested?
- Dexamethasone Plus Metoclopramide and Paracetamol/NSAIDs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Primary Headache
- Being tested
- Dexamethasone Plus Metoclopramide, Paracetamol/NSAIDs
- Keywords
- Dexamethasone, Metoclopramide, Paracetamol, NSAIDs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Plus MetoclopramideDrug
Participants will receive intravenous dexamethasone 8 mg in combination with intravenous metoclopramide 10 mg for treatment of primary headache in the emergency department.
Paracetamol/NSAIDsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Paracetamol/NSAIDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 minutes after administration of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Primary HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beenish Saquib, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605065
- Sponsor's protocol ID
- PEMH-EM-2026-001
- Other IDs
- ERC/29/26
- Acronym
- DMPH
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to institutional policies and confidentiality considerations. De-identified data may be made available by the principal investigator upon reasonable request and subject to institutional approval
Publications
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.
PubMed 33773613Herekar 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.
PubMed 282293208. 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.
PubMed 185416106. 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.
PubMed 33267788GBD 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.
PubMed 34487721
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07605065
- Acronym / sponsor ID
- DMPH / PEMH-EM-2026-001
- Conditions
- Primary Headache
- Keywords
- Dexamethasone, Metoclopramide, Paracetamol, NSAIDs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Plus Metoclopramide | Experimental | Drug: Dexamethasone Plus MetoclopramideParticipants in this arm will receive intravenous dexamethasone 8 mg combined with intravenous metoclopramide 10 mg for treatment of primary headache in the emergency department |
| Paracetamol/NSAIDs | Active comparator | Drug: Paracetamol/NSAIDsParticipants 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Plus MetoclopramideParticipants will receive intravenous dexamethasone 8 mg in combination with intravenous metoclopramide 10 mg for treatment of primary headache in the emergency department. | Drug | Dexamethasone Plus Metoclopramide |
| Paracetamol/NSAIDsParticipants 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 | Drug | Paracetamol/NSAIDs |
Primary outcome
Reduction in Pain Score by ≥50% on Visual Analogue Scale
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Results publication: PubMed 33773613Ashina 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.
- Results publication: PubMed 28229320Herekar 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.
- Results publication8. 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.
- Results publication: PubMed 18541610Colman 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.
- Results publication6. Huang Q, Yu H, Zhang N, Wang Y. Efficacy of dexamethasone in acute migraine management. Headache. 2020;60(7):1347-1355.
- Results publication5. 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.
- Results publication4. 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
- Results publication: PubMed 33267788Steiner 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.
- Results publication: PubMed 34487721GBD 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.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to institutional policies and confidentiality considerations. De-identified data may be made available by the principal investigator upon reasonable request and subject to institutional approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Plus Metoclopramide and Paracetamol/NSAIDs in people with Primary Headache, run by Pak Emirates Military Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beenish Saquib Beenish Saquib, FCPS (0320-8519818, Beenishsaquib2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Pain Score by ≥50% on Visual Analogue Scale (time frame: 60 minutes after administration of study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07605065, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.