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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

Tracking Information
First Submitted Date  ICMJE August 29, 2014
First Posted Date  ICMJE November 20, 2014
Results First Submitted Date  ICMJE August 4, 2016
Results First Posted Date  ICMJE April 2, 2018
Last Update Posted Date April 2, 2018
Study Start Date  ICMJE January 2012
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
Number of Participants With Adequate Relief of Headache as a Measure of Efficacy [ Time Frame: Primary outcome was six hours post administration ]
Number of participants with reduction in pain scores six hours post administration by at least 2 on the pain score scale.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
Number of Participants with Adequate relief of headache as a Measure of efficacious [ Time Frame: one year ]
Change History Complete list of historical versions of study NCT02295280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective.
Official Title  ICMJE Metoclopramide and Diphenhydramine (MAD): A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective (MAD Headache Study)
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
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 post-study questionnaire at 24 hours. Subjects who agree to participate in the study will have already tried a standard effective dose of acetaminophen (650 to 1000mg) without relief and are requesting further medication. Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV drawn up in the same syringe will be given to subjects randomized to Group A, while those randomized to Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet. Each subject will be asked if they had relief or persistence/recurrence of symptoms at 30 minutes, 1 hour and 6 hours after initial receipt of study medications. An additional dose of 10 mg IV metoclopramide + 25 mg IV diphenhydramine or codeine 30 mg tablets would be given at one hour if the patient did not have adequate relief the first time. If headache does not subside or recurs after second dose, regular non protocol medicines may be administered upon doctor recommendation. Patients will again be asked about headache at 24 hours and asked to complete a questionnaire regarding tolerance of medication, any adverse reactions experienced, persistence/recurrence of headache after administration of study medication, timing of occurrence with regard to administration, requirements of a second dose of study medication or other use of headache or nausea medication not included in protocol, satisfaction or relief of headache on a Likert scale from 0 to 10 after administration of medication if given at 1 hr interval.

Randomization Subjects will be randomized to GROUP A or GROUP B. An order will be placed to the SMHC pharmacy for the respective Group and will send up the medication assigned. The pharmacy will know which medications are in Group A and which are in Group B. On the pharmacy order sheet, the research team will indicate which group each subject is randomized to. The pharmacy will supply the medications and one of the nurses on the 5th floor will administer them.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Headache
Intervention  ICMJE
  • Drug: Metoclopramide
    IV
    Other Name: metoclopramide, Reglan, Reglan ODT, Metozol ODT, Octamide,
  • Drug: Diphenhydramine
    iv
    Other Name: Benadryl
  • Drug: Codeine
    PO
Study Arms  ICMJE
  • Active Comparator: Metoclopramide IV & Diphenhydramine IV
    Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV Group A
    Interventions:
    • Drug: Metoclopramide
    • Drug: Diphenhydramine
  • Active Comparator: Codeine
    Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet.
    Intervention: Drug: Codeine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2018)
70
Original Actual Enrollment  ICMJE
 (submitted: November 17, 2014)
300
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02295280
Other Study ID Numbers  ICMJE 15742
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dorothea Mostello, MD, St. Louis University
Study Sponsor  ICMJE St. Louis University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dorothea Mostello, MD St. Louis University
PRS Account St. Louis University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP