Trial Outcomes & Findings for Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches (NCT NCT01406860)

Results Overview

Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)

Results posted on

2017-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	11	8
Overall Study COMPLETED	11	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metoclopramide + Diphenhydramine n=8 Participants 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 n=19 Participants Total of all reporting groups	Droperidol n=11 Participants Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Age, Continuous	30.6 years STANDARD_DEVIATION 5.31 • n=7 Participants	32.6 years STANDARD_DEVIATION 7.85 • n=5 Participants	33.6 years STANDARD_DEVIATION 9.01 • n=5 Participants
Sex: Female, Male Female	7 Participants n=7 Participants	16 Participants n=5 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=7 Participants	19 Participants n=5 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)

Population: Data were not collected

Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours after discharge from ED

Population: Data were not collected

24 hour pain score (follow-up phone call)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the time when the treatment is initiated until the 24 hour follow-up phone survey

Population: Data were not collected

Frequency of adverse effects in each arm

Outcome measures

Outcome data not reported

Adverse Events

Droperidol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoclopramide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brett Faine

University of Iowa Hospitals and Clinics

Phone: 3193108067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place