Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 448 for:    diphenhydramine

Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02389829
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : June 5, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Hydromorphone
Drug: Prochlorperazine
Drug: Diphenhydramine
Enrollment 127
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydromorphone Prochlorperazine
Hide 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
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Hydromorphone Prochlorperazine Total
Hide 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 Number of Baseline Participants 64 63 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 63 participants 127 participants
35  (11) 32  (9) 34  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 63 participants 127 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 64 participants 63 participants 127 participants
64
 100.0%
63
 100.0%
127
 100.0%
Duration of headache Prior to Study  
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 64 participants 63 participants 127 participants
48
(24 to 96)
72
(24 to 96)
48
(24 to 96)
1.Primary Outcome
Title Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydromorphone Prochlorperazine
Hide 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

Overall Number of Participants Analyzed 64 63
Measure Type: Count of Participants
Unit of Measure: Participants
20
  31.3%
37
  58.7%
2.Secondary Outcome
Title Number of Participants Needing Rescue Medication as Assessed by Questionnaire
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydromorphone Prochlorperazine
Hide 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

Overall Number of Participants Analyzed 64 63
Measure Type: Count of Participants
Unit of Measure: Participants
23
  35.9%
4
   6.3%
3.Secondary Outcome
Title Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydromorphone Prochlorperazine
Hide 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

Overall Number of Participants Analyzed 64 62
Measure Type: Count of Participants
Unit of Measure: Participants
33
  51.6%
53
  85.5%
4.Secondary Outcome
Title Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydromorphone Prochlorperazine
Hide 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

Overall Number of Participants Analyzed 64 63
Measure Type: Count of Participants
Unit of Measure: Participants
16
  25.0%
29
  46.0%
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydromorphone Prochlorperazine
Hide 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 (%) Affected / at Risk (%)
Total   0/64 (0.00%)      0/63 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Hydromorphone Prochlorperazine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      0/63 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hydromorphone Prochlorperazine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/64 (20.31%)      7/63 (11.11%)    
General disorders     
Restlessness *  0/64 (0.00%)  0 3/63 (4.76%)  3
Other *  4/64 (6.25%)  4 4/63 (6.35%)  4
Nervous system disorders     
Dizzy *  9/64 (14.06%)  9 0/63 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Benjamin W. Friedman, MD, MS
Organization: Montefiore Medical Center
Phone: 718-920-6266
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02389829     History of Changes
Other Study ID Numbers: 2014-4325
First Submitted: March 10, 2015
First Posted: March 17, 2015
Results First Submitted: May 4, 2018
Results First Posted: June 5, 2018
Last Update Posted: August 31, 2018