Headache
Conditions
Keywords
headache, tension-type headache
Brief summary
Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.
Interventions
DRUGMetoclopramide
metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
DRUGKetorolac
ketorolac 30mg IVSS
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Acute tension type headache
Exclusion criteria
* Contraindications to investigational medications * Secondary cause of headache
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | Baseline, 60 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Scores | 24 hours | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from one emergency department (ED) in the Bronx, NY
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Ketorolac 30 mg, administered intravenously over 15 minutes | 60 |
| Metoclopramide metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 24 Hour Follow-up | Lost to Follow-up | 3 | 3 |
| Randomized | Secondary headache | 2 | 1 |
Baseline characteristics
| Characteristic | Metoclopramide | Total | Ketorolac |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 120 Participants | 60 Participants |
| Age, Continuous | 39 years STANDARD_DEVIATION 12 | 38 years STANDARD_DEVIATION 11 | 37 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 60 participants | 120 participants | 60 participants |
| Sex: Female, Male Female | 42 Participants | 90 Participants | 48 Participants |
| Sex: Female, Male Male | 18 Participants | 30 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 60 | 12 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Change in Pain Score
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Change in Pain Score | 3.8 units on a scale | Standard Deviation 2.6 |
| Metoclopramide | Change in Pain Score | 5.1 units on a scale | Standard Deviation 2.8 |
Secondary
Satisfaction Scores
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.
Time frame: 24 hours
Population: 3 patients in each group were lost to follow-up. All others are tabulated here.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac | Satisfaction Scores | 45 participants |
| Metoclopramide | Satisfaction Scores | 53 participants |