Trial Outcomes & Findings for Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department (NCT NCT02972502)
NCT ID: NCT02972502
Last Updated: 2018-10-23
Results Overview
Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)
Results posted on
2018-10-23
Participant Flow
Participant milestones
| Measure |
Metoclopramide (Reglan)
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
Haloperidol (Haldol)
Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Haloperidol: Patients receive 2.5 mg of IV haloperidol.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Metoclopramide (Reglan)
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
Haloperidol (Haldol)
Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Haloperidol: Patients receive 2.5 mg of IV haloperidol.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
Baseline characteristics by cohort
| Measure |
Metoclopramide (Reglan)
n=31 Participants
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
Haloperidol (Haldol)
n=29 Participants
Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Haloperidol: Patients receive 2.5 mg of IV haloperidol.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 9.9 • n=31 Participants
|
36.9 years
STANDARD_DEVIATION 10.0 • n=29 Participants
|
35.7 years
STANDARD_DEVIATION 10.0 • n=60 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=26 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
9 Participants
n=23 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
17 Participants
n=49 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
|
Sex: Female, Male
Male
|
18 Participants
n=26 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
14 Participants
n=23 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
32 Participants
n=49 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
18 Participants
n=26 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
19 Participants
n=23 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
37 Participants
n=49 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
6 Participants
n=26 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
4 Participants
n=23 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
10 Participants
n=49 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Somali
|
1 Participants
n=26 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
0 Participants
n=23 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
1 Participants
n=49 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=26 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
0 Participants
n=23 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
1 Participants
n=49 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
29 participants
n=29 Participants
|
60 participants
n=60 Participants
|
|
Baseline Pain Score
|
8.13 units on a scale
STANDARD_DEVIATION 1.36 • n=26 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
8.54 units on a scale
STANDARD_DEVIATION 1.34 • n=23 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
8.35 units on a scale
STANDARD_DEVIATION 1.38 • n=49 Participants • Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.
|
PRIMARY outcome
Timeframe: Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)Population: Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.
Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.
Outcome measures
| Measure |
Metoclopramide (Reglan)
n=26 Participants
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
Haloperidol (Haldol)
n=23 Participants
Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Haloperidol: Patients receive 2.5 mg of IV haloperidol.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
|---|---|---|
|
Change in Pain Score According to the Numeric Pain Intensity Scale
|
-2.86 units on a scale
Standard Deviation 2.37
|
-5.13 units on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: 48 hours post dischargePopulation: Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.
Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge
Outcome measures
| Measure |
Metoclopramide (Reglan)
n=26 Participants
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
Haloperidol (Haldol)
n=23 Participants
Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Haloperidol: Patients receive 2.5 mg of IV haloperidol.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
|---|---|---|
|
Need for Additional Medications Used in the Emergency Department (ED)
Unknown
|
15 Participants
|
10 Participants
|
|
Need for Additional Medications Used in the Emergency Department (ED)
Yes
|
7 Participants
|
4 Participants
|
|
Need for Additional Medications Used in the Emergency Department (ED)
No
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 48 hours post dischargePopulation: Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.
Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge
Outcome measures
| Measure |
Metoclopramide (Reglan)
n=26 Participants
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
Haloperidol (Haldol)
n=23 Participants
Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Haloperidol: Patients receive 2.5 mg of IV haloperidol.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.
|
|---|---|---|
|
Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge
Yes
|
0 Participants
|
0 Participants
|
|
Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge
No
|
26 Participants
|
23 Participants
|
Adverse Events
Metoclopramide (Reglan)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Haloperidol (Haldol)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place