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
|Condition or disease||Intervention/treatment||Phase|
|Headache||Drug: Metoclopramide Drug: Diphenhydramine Drug: Codeine||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metoclopramide and Diphenhydramine (MAD): A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective (MAD Headache Study)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Metoclopramide IV & Diphenhydramine IV
Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV Group A
Other Name: metoclopramide, Reglan, Reglan ODT, Metozol ODT, Octamide,
Other Name: Benadryl
Active Comparator: Codeine
Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295280
|United States, Missouri|
|Saint Louis University|
|Saint Louis, Missouri, United States, 63117|
|Principal Investigator:||Dorothea Mostello, MD||St. Louis University|