Trial Outcomes & Findings for Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department (NCT NCT02794441)
NCT ID: NCT02794441
Last Updated: 2019-12-03
Results Overview
The primary outcome will be headache recurrence 48 hours after discharge from the ED. Headache recurrence will be defined as: for patients who were pain-free at ED discharge (ie. pain intensity of 0), any return of head pain (ie. pain intensity of 1 or greater) will be coded as a recurrence, and for patients who had persistent head pain at discharge, an increase in head pain since ED discharge will be coded as recurrence as well (ie. an increase in their score on the 4-point scale as compared to their score at ED discharge).
COMPLETED
PHASE3
12 participants
48 hours
2019-12-03
Participant Flow
Participants were recruited between December 2016 and June 2017 from the ED at the Children's Hospital of Eastern Ontario, a tertiary care academic pediatric hospital located in Ottawa, Ontario, Canada.
Participant milestones
| Measure |
Dexamethasone
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.6 years
STANDARD_DEVIATION 3.4 • n=6 Participants
|
13.6 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
13.0 years
STANDARD_DEVIATION 2.6 • n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
11 participants
n=11 Participants
|
|
CTAS Score
Resuscitation
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
CTAS Score
Emergent
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
CTAS Score
Urgent
|
6 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=11 Participants
|
|
CTAS Score
Semi-Urgent
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
|
CTAS Score
Non-Urgent
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Baseline Pain Intensity
None
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Baseline Pain Intensity
Mild
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Baseline Pain Intensity
Moderate
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=11 Participants
|
|
Baseline Pain Intensity
Severe
|
4 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=11 Participants
|
|
Use of Treatment at Home
Yes
|
4 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=11 Participants
|
|
Use of Treatment at Home
No
|
2 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=11 Participants
|
|
Migraine Type
Migraine with aura
|
4 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=11 Participants
|
|
Migraine Type
Migraine without aura
|
3 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=11 Participants
|
|
Headache Frequency (Monthly Frequency in Past 3 Months)
|
12.6 Headaches
STANDARD_DEVIATION 12.9 • n=6 Participants
|
7.2 Headaches
STANDARD_DEVIATION 12.8 • n=5 Participants
|
10.3 Headaches
STANDARD_DEVIATION 12.6 • n=11 Participants
|
|
How Long Participant Has Had Migraines
|
5.1 years
STANDARD_DEVIATION 9.9 • n=6 Participants
|
2.0 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
3.6 years
STANDARD_DEVIATION 6.8 • n=11 Participants
|
|
PedMIDAS Score
|
58.7 units on a scale
STANDARD_DEVIATION 108.5 • n=6 Participants
|
16.2 units on a scale
STANDARD_DEVIATION 17.8 • n=5 Participants
|
41 units on a scale
STANDARD_DEVIATION 83.8 • n=11 Participants
|
PRIMARY outcome
Timeframe: 48 hoursThe primary outcome will be headache recurrence 48 hours after discharge from the ED. Headache recurrence will be defined as: for patients who were pain-free at ED discharge (ie. pain intensity of 0), any return of head pain (ie. pain intensity of 1 or greater) will be coded as a recurrence, and for patients who had persistent head pain at discharge, an increase in head pain since ED discharge will be coded as recurrence as well (ie. an increase in their score on the 4-point scale as compared to their score at ED discharge).
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Headache Recurrence at 48 Hours
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours)Pain intensity will be measured on a 4 point rating scale as recommended by the International Headache Society guidelines: a) 0=none, b) 1=mild, c) 2= moderate, d) 4=severe. It will be assessed at 2 hours post-baseline, or at the time of ED discharge if prior to 2 hours and at the time of ED discharge where this exceeds 2 hours post-intervention. Because all participants were discharged prior to 2 hours, we report the pain intensity at the time of ED discharge.
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Pain Intensity
None
|
2 Participants
|
1 Participants
|
|
Pain Intensity
Mild
|
2 Participants
|
2 Participants
|
|
Pain Intensity
Moderate
|
2 Participants
|
2 Participants
|
|
Pain Intensity
Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hoursPersistent pain freedom, defined as the proportion of patients in each group who achieved pain freedom at 2 hours (or at the time of ED discharge if prior to 2 hours) and were free of pain without the use of rescue medication at 48 hours, will be assessed
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Persistent Pain Freedom
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the time of discharge from the ED (expected median duration in the ED post-treatment = 3 hours), at 48 hours and at 7 day follow-upPatient satisfaction will be assessed at the time of discharge from the ED and again at follow-up with the following 5-point Likert scale: 5=very satisfied, 4=satisfied, 3=neutral, 2=unsatisfied, 1=very unsatisfied. Here we report patient satisfaction rates at discharge.
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Patient Satisfaction
At discharge · Satisfied
|
6 Participants
|
4 Participants
|
|
Patient Satisfaction
At discharge · Dissatisfied
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction
At 48 hour follow-up · Satisfied
|
6 Participants
|
4 Participants
|
|
Patient Satisfaction
At 48 hour follow-up · Dissatisfied
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction
At 7 day follow-up · Satisfied
|
6 Participants
|
3 Participants
|
|
Patient Satisfaction
At 7 day follow-up · Dissatisfied
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 daysThe proportion of patients in each group with recurrence within the 7 days following ED discharge will be assessed.
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Headache Recurrence at 7 Day Follow-up
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 daysThe number of patients with return ED visits within 7 days of ED discharge will be assessed through chart review.
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Revisits Within 7 Days of Discharge From the ED
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 daysAdverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the time of ED discharge. All patients were discharged prior to the 2 hour time point. Adverse events reported at follow-up are reported elsewhere (see below).
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Adverse Events at Discharge
Adverse events
|
0 Participants
|
0 Participants
|
|
Adverse Events at Discharge
No adverse events
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 daysAdverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the 48 hour follow-up post-discharge.
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Adverse Events at 48 Hours Post-discharge
Worsening headache
|
1 Participants
|
1 Participants
|
|
Adverse Events at 48 Hours Post-discharge
Fever
|
0 Participants
|
1 Participants
|
|
Adverse Events at 48 Hours Post-discharge
Constipation
|
1 Participants
|
0 Participants
|
|
Adverse Events at 48 Hours Post-discharge
No adverse events
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 daysAdverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the 7 day follow-up post-discharge.
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 Participants
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Adverse Events at 7 Days Post-discharge
Paresthesias
|
0 Participants
|
1 Participants
|
|
Adverse Events at 7 Days Post-discharge
Headache recurrence
|
0 Participants
|
1 Participants
|
|
Adverse Events at 7 Days Post-discharge
No adverse events
|
6 Participants
|
3 Participants
|
Adverse Events
Dexamethasone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexamethasone
n=6 participants at risk
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
|
Placebo
n=5 participants at risk
Matched oral solution in same volume per kg as dexamethasone
Placebo: Matched oral solution
|
|---|---|---|
|
Nervous system disorders
Worsening headache
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected at discharge and for the first 7 days after discharge
The medication (dexamethasone) has potential to cause immunosuppression.
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected at discharge and for the first 7 days after discharge
The medication (dexamethasone) has potential to cause immunosuppression.
|
|
Nervous system disorders
Paresthesias
|
0.00%
0/6 • Adverse event data were collected at discharge and for the first 7 days after discharge
The medication (dexamethasone) has potential to cause immunosuppression.
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected at discharge and for the first 7 days after discharge
The medication (dexamethasone) has potential to cause immunosuppression.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected at discharge and for the first 7 days after discharge
The medication (dexamethasone) has potential to cause immunosuppression.
|
0.00%
0/5 • Adverse event data were collected at discharge and for the first 7 days after discharge
The medication (dexamethasone) has potential to cause immunosuppression.
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse event data were collected at discharge and for the first 7 days after discharge
The medication (dexamethasone) has potential to cause immunosuppression.
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected at discharge and for the first 7 days after discharge
The medication (dexamethasone) has potential to cause immunosuppression.
|
Additional Information
Dr. Roger Zemek
Children's Hospital of Eastern Ontario Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place