Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02389829
• Collaborator: (none)
• Enrollment: 127
• Location: 1
• Arms: 2
• Duration (Months): 19.1
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Hydromorphone; Drug: Prochlorperazine; Drug: Diphenhydramine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hydromorphone Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.	Drug: Hydromorphone; Other Names: Dilaudid
Active Comparator: Prochlorperazine Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour.	Drug: Prochlorperazine; Other Names: Compazine ; Drug: Diphenhydramine; Other Names: Benadryl

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center--Einstein	Bronx	New York	United States	10461

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, Associate Professor, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT02389829
• Other Study ID Numbers: 2014-4325
• First Posted: Mar 17, 2015
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Migraine Disorders; Diphenhydramine; Promethazine; Hydromorphone; Prochlorperazine

Study Results

Participant Flow

Arm/Group Title	Hydromorphone	Prochlorperazine
Arm/Group Description	Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Period Title: Overall Study
STARTED	64	63
COMPLETED	64	62
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Hydromorphone	Prochlorperazine	Total
Arm/Group Description	Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	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 of all reporting groups
Overall Participants	64	63	127
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35 (11)	32 (9)	34 (10)
Sex: Female, Male (Count of Participants)
Female	56 87.5%	50 79.4%	106 83.5%
Male	8 12.5%	13 20.6%	21 16.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	64 100%	63 100%	127 100%
Duration of headache Prior to Study (Hours) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Hours]	48	72	48

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hydromorphone	Prochlorperazine
Arm/Group Description	Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Measure Participants	64	63
Count of Participants [Participants]	20 31.3%	37 58.7%

2. Secondary Outcome

Title	Number of Participants Needing Rescue Medication as Assessed by Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hydromorphone	Prochlorperazine
Arm/Group Description	Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Measure Participants	64	63
Count of Participants [Participants]	23 35.9%	4 6.3%

3. Secondary Outcome

Title	Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hydromorphone	Prochlorperazine
Arm/Group Description	Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Measure Participants	64	62
Count of Participants [Participants]	33 51.6%	53 84.1%

4. Secondary Outcome

Title	Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hydromorphone	Prochlorperazine
Arm/Group Description	Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone	Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
Measure Participants	64	63
Count of Participants [Participants]	16 25%	29 46%

Adverse Events

Time Frame	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.
Arm/Group Title	Hydromorphone		Prochlorperazine
Arm/Group Description	Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Hydromorphone		Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine
All Cause Mortality
	Hydromorphone		Prochlorperazine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/63 (0%)
Serious Adverse Events
	Hydromorphone		Prochlorperazine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Hydromorphone		Prochlorperazine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/64 (20.3%)		7/63 (11.1%)
General disorders
Restlessness	0/64 (0%)	0	3/63 (4.8%)	3
Other	4/64 (6.3%)	4	4/63 (6.3%)	4
Nervous system disorders
Dizzy	9/64 (14.1%)	9	0/63 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.