N/A N=70 Randomized Prevention

A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective.

Headache

Bottom Line

View on ClinicalTrials.gov: NCT02295280 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Number of Participants With Adequate Relief of Headache as a Measure of Efficacy — 34; 32 Participants — p=0.14

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Metoclopramide (Drug); Diphenhydramine (Drug); Codeine (Drug)
Age: Pediatric, Adult · 16+ yrs
Sex: Female
Sponsor: St. Louis University
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adequate Relief of Headache as a Measure of Efficacy	34; 32	0.14

Summary

To determine if the intravenous administration of Metoclopramide and diphenhydramine in combination can effectively treat headaches in pregnant patients in those refractory to acetaminophen when compared to codeine

Eligibility Criteria

Inclusion Criteria

Pregnant women age 16 or older, admitted to the hospital or treated in the triage unit at 14 weeks gestation or greater, with subjective symptoms of persistent headache despite 650-1000 mg acetaminophen taken more than one hour before administration of study medication.

Exclusion Criteria

Treatment with another headache-aborting medication other than acetaminophen within 24 hours Allergy to metoclopramide, diphenhydramine, or codeine Systolic blood pressure >/= 140 Diastolic blood pressure >/= 90 History of brain tumor Active diagnosis of hyperemesis Acute asthma exacerbation at time of presentation Active labor

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Data sourced from ClinicalTrials.gov (NCT02295280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.