MedDataX Logo

Trial Outcomes & Findings for Metoclopramide Versus Ketorolac for Tension-type Headache (NCT NCT01011673)

NCT ID: NCT01011673

Last Updated: 2018-05-15

Results Overview

At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

123 participants

Primary outcome timeframe

Baseline, 60 minutes

Results posted on

2018-05-15

Participant Flow

Patients were recruited from one emergency department (ED) in the Bronx, NY

Participant milestones

Participant milestones
Measure
Ketorolac
Ketorolac 30 mg, administered intravenously over 15 minutes
Metoclopramide
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Randomized
STARTED
62
61
Randomized
COMPLETED
60
60
Randomized
NOT COMPLETED
2
1
Emergency Department Portion
STARTED
60
60
Emergency Department Portion
COMPLETED
60
60
Emergency Department Portion
NOT COMPLETED
0
0
24 Hour Follow-up
STARTED
60
60
24 Hour Follow-up
COMPLETED
57
57
24 Hour Follow-up
NOT COMPLETED
3
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Ketorolac
Ketorolac 30 mg, administered intravenously over 15 minutes
Metoclopramide
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Randomized
Secondary headache
2
1
24 Hour Follow-up
Lost to Follow-up
3
3

Baseline Characteristics

Metoclopramide Versus Ketorolac for Tension-type Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ketorolac
n=60 Participants
Ketorolac 30 mg, administered intravenously over 15 minutes
Metoclopramide
n=60 Participants
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Total
n=120 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
60 Participants
n=5 Participants
60 Participants
n=7 Participants
120 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
37 years
STANDARD_DEVIATION 10 • n=5 Participants
39 years
STANDARD_DEVIATION 12 • n=7 Participants
38 years
STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male
Female
48 Participants
n=5 Participants
42 Participants
n=7 Participants
90 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
18 Participants
n=7 Participants
30 Participants
n=5 Participants
Region of Enrollment
United States
60 participants
n=5 Participants
60 participants
n=7 Participants
120 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 60 minutes

Population: 3 randomized patients were not included in this analysis. During the ED visit, these patients were diagnosed with intracranial hemorrhage, brain abscess, and malaria and therefore did not truly have a primary headache disorder. Including these patients, 123 were randomized.

At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score

Outcome measures

Outcome measures
Measure
Ketorolac
n=60 Participants
Ketorolac 30 mg, administered intravenously over 15 minutes
Metoclopramide
n=60 Participants
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Change in Pain Score
3.8 units on a scale
Standard Deviation 2.6
5.1 units on a scale
Standard Deviation 2.8

SECONDARY outcome

Timeframe: 24 hours

Population: 3 patients in each group were lost to follow-up. All others are tabulated here.

24 hours after the emergency department visit, patients were asked, "The next time you come to the Er with this type of headache, do you want to receive the same medication?" Affirmative answers are tabulated here.

Outcome measures

Outcome measures
Measure
Ketorolac
n=57 Participants
Ketorolac 30 mg, administered intravenously over 15 minutes
Metoclopramide
n=57 Participants
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Satisfaction Scores
45 participants
53 participants

Adverse Events

Ketorolac

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Metoclopramide

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Ketorolac
n=60 participants at risk
Ketorolac 30 mg, administered intravenously over 15 minutes
Metoclopramide
n=60 participants at risk
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Gastrointestinal disorders
Nausea
3.3%
2/60 • Number of events 2
1.7%
1/60 • Number of events 1
Nervous system disorders
Akathisia
13.3%
8/60 • Number of events 8
13.3%
8/60 • Number of events 8
Nervous system disorders
Dizziness
3.3%
2/60 • Number of events 2
3.3%
2/60 • Number of events 2
Gastrointestinal disorders
Epigastric pain
1.7%
1/60 • Number of events 1
1.7%
1/60 • Number of events 1
Musculoskeletal and connective tissue disorders
musculoskeletal pain
1.7%
1/60 • Number of events 1
1.7%
1/60 • Number of events 1

Additional Information

Benjamin Friedman, MD

Montefiore Medical Center, Albert Einstein College of Medicine

Phone: 718-920-6626

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place