Headache
Conditions
Keywords
headache
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.
Interventions
Sponsors
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adequate Relief of Headache as a Measure of Efficacy | 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. |
Countries
United States
Participant flow
Recruitment details
This was a prospective randomized, controlled trial at a single perinatal care center, conducted from December 2012 through September 2014 and approved by the IRB at Saint Louis University.
Participants by arm
| Arm | Count |
|---|---|
| Metoclopramide IV & Diphenhydramine IV Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache. | 35 |
| Codeine Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache. | 34 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Codeine | Metoclopramide IV & Diphenhydramine IV |
|---|---|---|---|
| Age, Continuous | 23 years | 23.5 years | 23 years |
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Between 18 and 65 years | 69 Participants | 34 Participants | 35 Participants |
| Region of Enrollment United States | 69 participants | 34 participants | 35 participants |
| Sex: Female, Male Female | 69 Participants | 34 Participants | 35 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Number of Participants With Adequate Relief of Headache as a Measure of Efficacy
Number of participants with reduction in pain scores six hours post administration by at least 2 on the pain score scale.
Time frame: Primary outcome was six hours post administration
Population: Number in each arm with data at 6 hours who received either metoclopramide and diphenhydramine IV or codeine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metoclopramide IV & Diphenhydramine IV | Number of Participants With Adequate Relief of Headache as a Measure of Efficacy | 34 Participants |
| Codeine | Number of Participants With Adequate Relief of Headache as a Measure of Efficacy | 32 Participants |
Comparison: A sample size calculation of 35 patients in each group was based on an estimated reduction in headache pain score by at least two points, with an a of 0.05 and power of 90%, which is similar to estimates reported in prior studies in non-pregnant patients and felt to be a clinically significant decrease. Statistical analyses were performed using chi-square, Fisher's exact test for categorical variables, the independent Student's t-test and Kolmogorov-Smirnov for continuous variables.p-value: 0.14Mann Whitney U test