Migraine
Conditions
Brief summary
Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.
Interventions
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
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Migraine headache (International Classification of Headache Disorders 3B criteria)
Exclusion criteria
* Brain imaging ordered * Fever * Objective neurological findings * Pregnancy/ breast feeding * Allergy/ contraindication to investigational medication * History of addiction to opioids, use of methadone, any use of opioids previous 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sustained Headache Relief Assessed by Self-evaluation | up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department | 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, without use of addition medication. 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 |
|---|---|---|
| Number of Participants Needing Rescue Medication as Assessed by Questionnaire | 48 hours after discharge from Emergency Department | Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication. |
| Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire | 48 hours after discharge from Emergency Department | Participants were asked to make evaluation of pain status since discharge. Those achieving headache level mild or none for 1 hour are considered to achieve short term headache relief. |
| Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire | 48 hours after discharge from Emergency Department | Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydromorphone Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.
Hydromorphone | 64 |
| Prochlorperazine Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.
Patients can receive second 10mg dose at 1 hour.
Prochlorperazine
Diphenhydramine | 63 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Hydromorphone | Prochlorperazine | Total |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 11 | 32 years STANDARD_DEVIATION 9 | 34 years STANDARD_DEVIATION 10 |
| Duration of headache Prior to Study | 48 Hours | 72 Hours | 48 Hours |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 64 Participants | 63 Participants | 127 Participants |
| Sex: Female, Male Female | 56 Participants | 50 Participants | 106 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 63 |
| other Total, other adverse events | 13 / 64 | 7 / 63 |
| serious Total, serious adverse events | 0 / 64 | 0 / 63 |
Outcome results
Primary
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
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, without use of addition medication. 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: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants With Sustained Headache Relief Assessed by Self-evaluation | 20 Participants |
| Prochlorperazine | Number of Participants With Sustained Headache Relief Assessed by Self-evaluation | 37 Participants |
Secondary
Number of Participants Needing Rescue Medication as Assessed by Questionnaire
Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication.
Time frame: 48 hours after discharge from Emergency Department
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants Needing Rescue Medication as Assessed by Questionnaire | 23 Participants |
| Prochlorperazine | Number of Participants Needing Rescue Medication as Assessed by Questionnaire | 4 Participants |
Secondary
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief.
Time frame: 48 hours after discharge from Emergency Department
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire | 16 Participants |
| Prochlorperazine | Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire | 29 Participants |
Secondary
Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
Participants were asked to make evaluation of pain status since discharge. Those achieving headache level mild or none for 1 hour are considered to achieve short term headache relief.
Time frame: 48 hours after discharge from Emergency Department
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire | 33 Participants |
| Prochlorperazine | Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire | 53 Participants |