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

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