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

NCT02295280 | Completed Results DMC

• 1 other identifier: 15742
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 compared to codeine

Conditions

Headache

Keywords

headache

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adequate Relief of Headache as a Measure of Efficacy

  Number of participants with reduction in pain scores six hours post administration by at least 2 on the pain score scale.

  Primary outcome was six hours post administration

Study Arms (2)

Metoclopramide IV & Diphenhydramine IV

ACTIVE COMPARATOR

Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV Group A

Drug: Metoclopramide; Drug: Diphenhydramine

Codeine

ACTIVE COMPARATOR

Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet.

Drug: Codeine

Interventions

Metoclopramide DRUG

IV

Also known as: metoclopramide, Reglan, Reglan ODT, Metozol ODT, Octamide,

Metoclopramide IV & Diphenhydramine IV

Diphenhydramine DRUG

iv

Also known as: Benadryl

Metoclopramide IV & Diphenhydramine IV

Codeine DRUG

PO

Codeine

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Metoclopramide; Diphenhydramine; Codeine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Ethylamines; Amines; Benzhydryl Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

One of the limitations of our study is that codeine was used as standard for comparison to the MAD regimen. This was due to poor patient enrollment with an earlier study design comparing MAD to placebo.

Results Point of Contact

• Title: Dorothea Mostello, MD, Maternal Fetal Medicine Faculty
• Organization: Saint Louis University

mostello@slu.edu

314-977-2090

Study Officials

• Dorothea Mostello, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: November 20, 2014
• Study Start: January 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 2, 2018
• Results First Posted: April 2, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)