Post-Traumatic Headache
Conditions
Brief summary
Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.
Interventions
DRUGMetoclopramide
Metoclopramide 20mg
DRUGDiphenhydramine
Diphenhydramine 25mg
DRUGNormal saline
100ml normal saline
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows: * 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.
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 MAO inhibitors, and use of anti-rejection transplant medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable | 1 hour after medication administration | Improvement in this 0 to 10 verbal rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Headache Relief | 48 hours after medication administration | Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe |
| Headache Days | 7 days after ED visit | Number of days with any headache. Participants report the actual number of days they experienced headache. A day begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metoclopramide Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
Metoclopramide: Metoclopramide 20mg
Diphenhydramine: Diphenhydramine 25mg
Normal saline: 100ml normal saline | 81 |
| Placebo Normal saline, administered as an intravenous drip
Normal saline: 100ml normal saline | 79 |
| Total | 160 |
Baseline characteristics
| Characteristic | Metoclopramide | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 16 | 46 years STANDARD_DEVIATION 17 | 45 years STANDARD_DEVIATION 16 |
| Baseline pain intensity, as measured on a 0-10 scale | 8.3 units on a scale STANDARD_DEVIATION 1.6 | 8.3 units on a scale STANDARD_DEVIATION 1.5 | 8.3 units on a scale STANDARD_DEVIATION 1.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 81 participants | 79 participants | 160 participants |
| Sex: Female, Male Female | 51 Participants | 56 Participants | 107 Participants |
| Sex: Female, Male Male | 30 Participants | 23 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 79 |
| other Total, other adverse events | 35 / 81 | 22 / 79 |
| serious Total, serious adverse events | 0 / 81 | 0 / 79 |
Outcome results
Primary
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
Improvement in this 0 to 10 verbal rating scale
Time frame: 1 hour after medication administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metoclopramide | 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable | 5.2 units on a scale | Standard Deviation 2.3 |
| Placebo | 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable | 3.8 units on a scale | Standard Deviation 2.6 |
Secondary
Headache Days
Number of days with any headache. Participants report the actual number of days they experienced headache. A day begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities
Time frame: 7 days after ED visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metoclopramide | Headache Days | 3.3 days | Standard Deviation 1.6 |
| Placebo | Headache Days | 3.3 days | Standard Deviation 1.6 |
Secondary
Sustained Headache Relief
Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe
Time frame: 48 hours after medication administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metoclopramide | Sustained Headache Relief | 24 Participants |
| Placebo | Sustained Headache Relief | 18 Participants |