Post-Traumatic Headache
Conditions
Brief summary
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
Interventions
DRUGMetoclopramide
Intravenous medication drip
DRUGDiphenhydramine
Intravenous medication drip
Sponsors
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Traumatic injury to the head has occurred * Headache has developed within 7 days of injury to the head * Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache) * The headache must be rated as moderate or severe in intensity at the time of initial evaluation. * The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
Exclusion criteria
* Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sustained Headache Relief | 2 hours thru 48 hours after treatment | Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Concussion Symptoms Assessed by Post-concussive Symptom Scale | 7 days | The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms. |
| Number of Participants Satisfied With Medication; Assessed by Self-evaluation | 48 hours after treatment | Satisfaction is measured by a positive response to the question Would you want to receive the same medication during a subsequent visit for post-traumatic headache? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metoclopramide Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
Metoclopramide: Intravenous medication drip
Diphenhydramine: Intravenous medication drip | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Metoclopramide | — |
|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 18 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 21 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 2 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Number of Participants With Sustained Headache Relief
Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.
Time frame: 2 hours thru 48 hours after treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metoclopramide | Number of Participants With Sustained Headache Relief | 12 Participants |
Secondary
Number of Participants Satisfied With Medication; Assessed by Self-evaluation
Satisfaction is measured by a positive response to the question Would you want to receive the same medication during a subsequent visit for post-traumatic headache?
Time frame: 48 hours after treatment
Population: 2 patients did not provide an answer to this question
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metoclopramide | Number of Participants Satisfied With Medication; Assessed by Self-evaluation | 16 Participants |
Secondary
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.
Time frame: 7 days
Population: 2 patients were lost to followup
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metoclopramide | Post Concussion Symptoms Assessed by Post-concussive Symptom Scale | 11.4 units on a scale | Standard Deviation 21.4 |