Status:
COMPLETED
A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective.
Lead Sponsor:
St. Louis University
Conditions:
Headache
Eligibility:
FEMALE
16-50 years
Phase:
NA
Brief 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 compa...
Detailed Description
This is a randomized, controlled study based on prospective collection of data during the study subjects' hospital stays, questioning at 30 minutes and 1, 6, and 24 hours after administration, and a p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02295280
Start Date
January 1 2012
End Date
November 1 2014
Last Update
April 2 2018
Active Locations (1)
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1
Saint Louis University
St Louis, Missouri, United States, 63117