A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective.
Condition: Headache
MeSH terms: Headache
Study type: Interventional

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.
    

Intervention name(s): Metoclopramide; Diphenhydramine; Codeine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV; iv; PO
Other intervention name(s): metoclopramide, Reglan, Reglan ODT, Metozol ODT, Octamide,; Benadryl
Intervention MeSH terms: Diphenhydramine; Promethazine; Codeine; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: headache