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Ketorolac and metoclopramide in acute migraine headache.

The comparison of intravenous ketorolac and intravenous metoclopramide analgesic effect in patients with acute migraine headache referring to emergency department.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016010425854N1
Enrollment
100
Registered
2016-08-21
Start date
2016-06-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute migraine headache. Migraine

Interventions

Intervention 1: Ketorolac 30 mg intravenous. Intervention 2: Metoclopramide 20 mg intravenous. Intervention 3: Biperidine 5 mg intravenous for prevention of metoclopramide side effects. Intervention 4
Treatment - Drugs
Prevention
Placebo
Ketorolac 30 mg intravenous.
Metoclopramide 20 mg intravenous.
Biperidine 5 mg intravenous for prevention of metoclopramide side effects.
Aquapura 5 cc as placebo of biperidine.

Sponsors

Student research committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age older than 15 and younger than 70 years; History of migraine headache with or without aura. Exclusion criteria: Age younger than 15 or older than 70 years; Duration of headache less than 4 or over 72 hours; Patients who had undergone lumbar puncturation(LP) since last 48 hours; Patients who had a systemic headache; Body temperature more than 38 degrees of Celsius; Neurologic deficit; Allergy or tolerance to drugs of study; Participated in other study; Pregnant women; If the patient within 12 hours before entering to the center, received analgesic drug; Patients who for any reason are used analgesics on a daily basis; Patients who can not communicate verbally; If the patient's lost the consciousness due to alcohol consumption and or other material is gone; People with stomach ulcers and severe digestive problems (especially chronic diarrhea); Renal failure; Liver failure; Patients who suffer simultaneously from headaches other than migraine such as tension headaches or sinusitis; If the patient is receiving anticoagulant (due to drug interactions with ketorolac); If the patient is taking probenecid (due to increasing half-life of ketorolac); If the patient receiving phenothiazines, lithium or anti epileptic drugs (due to drug interactions with metoclopramide ); If the patient prior to entering the study have akathisia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of headache. Timepoint: A moment before the injection, 30 minutes, 60 minutes, 2 hours, 4 hours and 24 hours after the injection. Method of measurement: Visual analoge scale.;24 hours following up. Timepoint: 24 hours after the injection. Method of measurement: After 24 hours, patients are called and asked them to say the severity of their headache as this follow; severe, moderate, mild headache and without headache.

Secondary

MeasureTime frame
Severity of vertigo( as a side effect of study medication). Timepoint: A moment before injection, 1 hours and 2 hours after injection. Method of measurement: Without vertigo, Mild to moderate vertigo but able to do activities, Sever vertigo and inability to do activities.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArslan Tahmasbi

Ahvaz Jundishapur University of Medical Sciences.

tahmasbi.a@ajums.ac.irarsalan.tahmasbi@yahoo.com+98 61 3224 7507

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026