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