Trial Outcomes & Findings for Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine (NCT NCT02389829)

NCT ID: NCT02389829

Last Updated: 2018-08-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 127 participants
• Primary outcome timeframe: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
• Results posted on: 2018-08-31

Participant Flow

Participant milestones

Measure	Hydromorphone Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	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
Overall Study STARTED	64	63
Overall Study COMPLETED	64	62
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Hydromorphone Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	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
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hydromorphone n=64 Participants Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine n=63 Participants Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine	Total n=127 Participants Total of all reporting groups
Age, Continuous	35 years STANDARD_DEVIATION 11 • n=64 Participants	32 years STANDARD_DEVIATION 9 • n=63 Participants	34 years STANDARD_DEVIATION 10 • n=127 Participants
Sex: Female, Male Female	56 Participants n=64 Participants	50 Participants n=63 Participants	106 Participants n=127 Participants
Sex: Female, Male Male	8 Participants n=64 Participants	13 Participants n=63 Participants	21 Participants n=127 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	64 Participants n=64 Participants	63 Participants n=63 Participants	127 Participants n=127 Participants
Duration of headache Prior to Study	48 Hours n=64 Participants	72 Hours n=63 Participants	48 Hours n=127 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hydromorphone n=64 Participants Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine n=63 Participants Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation	20 Participants	37 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hydromorphone n=64 Participants Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine n=63 Participants Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Number of Participants Needing Rescue Medication as Assessed by Questionnaire	23 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hydromorphone n=64 Participants Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine n=62 Participants Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire	33 Participants	53 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hydromorphone n=64 Participants Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine n=63 Participants Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire	16 Participants	29 Participants

Adverse Events

Hydromorphone

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Prochlorperazine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hydromorphone n=64 participants at risk Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine n=63 participants at risk Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Nervous system disorders Dizzy	14.1% 9/64 • Number of events 9 • Adverse events were assessed by patient-initiated reports. In several cases, the explicit adverse event name/description was not documented. These events were grouped into the category called "other". Adverse events assessed over 48 hours post-treatment.	0.00% 0/63 • Adverse events were assessed by patient-initiated reports. In several cases, the explicit adverse event name/description was not documented. These events were grouped into the category called "other". Adverse events assessed over 48 hours post-treatment.
General disorders Restlessness	0.00% 0/64 • Adverse events were assessed by patient-initiated reports. In several cases, the explicit adverse event name/description was not documented. These events were grouped into the category called "other". Adverse events assessed over 48 hours post-treatment.	4.8% 3/63 • Number of events 3 • Adverse events were assessed by patient-initiated reports. In several cases, the explicit adverse event name/description was not documented. These events were grouped into the category called "other". Adverse events assessed over 48 hours post-treatment.
General disorders Other	6.2% 4/64 • Number of events 4 • Adverse events were assessed by patient-initiated reports. In several cases, the explicit adverse event name/description was not documented. These events were grouped into the category called "other". Adverse events assessed over 48 hours post-treatment.	6.3% 4/63 • Number of events 4 • Adverse events were assessed by patient-initiated reports. In several cases, the explicit adverse event name/description was not documented. These events were grouped into the category called "other". Adverse events assessed over 48 hours post-treatment.

Additional Information

Benjamin W. Friedman, MD, MS

Montefiore Medical Center

Phone: 718-920-6266

Email: befriedm@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place