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Trial record 11 of 74 for:    Codeine AND Acetaminophen

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

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ClinicalTrials.gov Identifier: NCT02295280
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Dorothea Mostello, MD, St. Louis University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Headache
Interventions Drug: Metoclopramide
Drug: Diphenhydramine
Drug: Codeine
Enrollment 70
Recruitment Details This was a prospective randomized, controlled trial at a single perinatal care center, conducted from December 2012 through September 2014 and approved by the IRB at Saint Louis University.
Pre-assignment Details  
Arm/Group Title Metoclopramide IV & Diphenhydramine IV Codeine
Hide Arm/Group Description

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

Metoclopramide: IV

Diphenhydramine: iv

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

Codeine: PO

Period Title: Overall Study
Started 35 35
Completed 35 34
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Metoclopramide IV & Diphenhydramine IV Codeine Total
Hide Arm/Group Description Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache. Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache. Total of all reporting groups
Overall Number of Baseline Participants 35 34 69
Hide Baseline Analysis Population Description
Baseline demographic characteristics were similar between the two groups.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
34
 100.0%
69
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants 34 participants 69 participants
23
(21 to 25)
23.5
(21 to 27)
23
(21 to 27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
Female
35
 100.0%
34
 100.0%
69
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 34 participants 69 participants
35 34 69
1.Primary Outcome
Title Number of Participants With Adequate Relief of Headache as a Measure of Efficacy
Hide Description Number of participants with reduction in pain scores six hours post administration by at least 2 on the pain score scale.
Time Frame Primary outcome was six hours post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Number in each arm with data at 6 hours who received either metoclopramide and diphenhydramine IV or codeine.
Arm/Group Title Metoclopramide IV & Diphenhydramine IV Codeine
Hide Arm/Group Description:
Number of patients who received Metoclopramide & diphenhydramine IV
Number of patients who received codeine
Overall Number of Participants Analyzed 34 32
Measure Type: Count of Participants
Unit of Measure: Participants
34
 100.0%
32
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Metoclopramide IV & Diphenhydramine IV, Codeine
Comments A sample size calculation of 35 patients in each group was based on an estimated reduction in headache pain score by at least two points, with an a of 0.05 and power of 90%, which is similar to estimates reported in prior studies in non-pregnant patients and felt to be a clinically significant decrease. Statistical analyses were performed using chi-square, Fisher's exact test for categorical variables, the independent Student's t-test and Kolmogorov-Smirnov for continuous variables.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments Reduction in pain scores by at least 2 units six hours post administration
Method Mann Whitney U test
Comments Mann Whitney U test used for analysis of this continuous variable as data were not normally distributed. Outcome was comparable at the 6-hour mark.
Time Frame 24 hours
Adverse Event Reporting Description No SAEs
 
Arm/Group Title Metoclopramide & Diphenhydramine Codeine
Hide Arm/Group Description Participants received intravenous metoclopramine (10 mg) and diphenhydramine (25 mg), up to two doses of each medication. Participants received oral 30 mg of oral codeine (up to two doses).
All-Cause Mortality
Metoclopramide & Diphenhydramine Codeine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Metoclopramide & Diphenhydramine Codeine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metoclopramide & Diphenhydramine Codeine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dorothea Mostello, MD, Maternal Fetal Medicine Faculty
Organization: Saint Louis University
Phone: 314-977-2090
EMail: mostello@slu.edu
Layout table for additonal information
Responsible Party: Dorothea Mostello, MD, St. Louis University
ClinicalTrials.gov Identifier: NCT02295280     History of Changes
Other Study ID Numbers: 15742
First Submitted: August 29, 2014
First Posted: November 20, 2014
Results First Submitted: August 4, 2016
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018