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Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

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: NCT01406860
Recruitment Status : Terminated (lack of enrollment/drug shortages)
First Posted : August 1, 2011
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
Interventions: Drug: Droperidol
Drug: Metoclopramide + diphenhydramine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Droperidol Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Metoclopramide + Diphenhydramine Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.

Participant Flow:   Overall Study
    Droperidol   Metoclopramide + Diphenhydramine
STARTED   11   8 
COMPLETED   11   8 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Droperidol Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Metoclopramide + Diphenhydramine

Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.

Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.

Total Total of all reporting groups

Baseline Measures
   Droperidol   Metoclopramide + Diphenhydramine   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   8   19 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.6  (9.01)   30.6  (5.31)   32.6  (7.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  81.8%      7  87.5%      16  84.2% 
Male      2  18.2%      1  12.5%      3  15.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   11   8   19 


  Outcome Measures

1.  Primary:   Pain Scale (Numerical Rating Scale for Pain)   [ Time Frame: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS) ]

2.  Secondary:   Length of Stay   [ Time Frame: Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes) ]

3.  Secondary:   24 Hour Pain Score   [ Time Frame: 24 hours after discharge from ED ]

4.  Secondary:   Adverse Effects   [ Time Frame: From the time when the treatment is initiated until the 24 hour follow-up phone survey ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Brett Faine
Organization: University of Iowa Hospitals and Clinics
phone: 3193108067
e-mail: brett-faine@uiowa.edu



Responsible Party: Brett A Faine, University of Iowa
ClinicalTrials.gov Identifier: NCT01406860     History of Changes
Other Study ID Numbers: 201008798
University of Iowa
First Submitted: September 22, 2010
First Posted: August 1, 2011
Results First Submitted: June 21, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017