The effect of two different doses of haloperidol in reducing the severity of acute migraine headache

Phase 2

Conditions: Common Migraine.
Migraine without aura [common migraine]

Registration Number: IRCT2016091215640N3

Lead Sponsor: Vice chancellor for research, Shahid Beheshti University of Medical Sciences

Brief Summary: Background: The present study was carried out with the aim of assessing the effectiveness of 2.5 mg dose of haloperidol compared with its standard 5 mg dose in relieving symptoms of cluster headaches and finding out to what extent the dopaminergic pathway affects the incidence of cluster headaches. Methods: The present study is a double-blind randomized clinical trial carried out in 3 health centers, Tehran, Iran. Patients diagnosed with cluster headache were treated by intravenous administration of 2.5 and 5 mg of haloperidol. Using a standard visual analog scale, pain severity was recorded before and 30, 60, 90, and 120 minutes after intervention. Treatment success (at least 3 points decrease in pain severity), side effects and recurrence of the headache were evaluated. Results: Finally, 42 patients were treated with 2.5 mg dose of haloperidol and 41 were in the 5 mg dose haloperidol treatment group. 40 (95.2%) patients who were treated with 2.5 mg dose of haloperidol experienced a significant decrease in pain (at least 3 points decrease in pain severity) in the initial 30 minutes. During this time, all of the patients (success rate=100%) treated with 5 mg dose of the drug had a significant decrease in pain. The two doses did not have a significant difference regarding treatment success (p=0.42). Conclusion: Results of the present study showed that both 2.5 and 5 mg doses of haloperidol have similar effectiveness in reducing cluster headaches. The high success rate observed indicates that hyperactivity of dopaminergic pathway plays an important role in onset of cluster headaches.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 100

Inclusion Criteria

Moderate to severe pain (pain score>4); with History of at least five attacks lasts 4 to 72 hours and headache has at least two of the following characteristics: Unilateral location, Pulsating quality, Moderate to severe pain intensity, Aggravation by or causing avoidance of routine physical activity; At least one of the following during headache: Nausea or vomiting (or both), Photophobia and phonophobia; Not attributable to another disorder
Exclusion criteria: First episode of headache; history of allergy to haloperidol; Pregnancy; Breast feeding; Renal failure; Hepatic failure; using other analgesics

Exclusion Criteria

Not provided