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Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department

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ClinicalTrials.gov Identifier: NCT02794441
Recruitment Status : Completed
First Posted : June 9, 2016
Results First Posted : December 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Roger Zemek, Children's Hospital of Eastern Ontario

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Dexamethasone
Other: Placebo
Enrollment 12
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Period Title: Overall Study
Started 7 5
Completed 6 5
Not Completed 1 0
Arm/Group Title Dexamethasone Placebo Total
Hide Arm/Group Description

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
One participant in the dexamethasone group withdrew from the study prior to receiving the study intervention and is not included in the analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 11 participants
12.6  (3.4) 13.6  (0.9) 13.0  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
5
  83.3%
2
  40.0%
7
  63.6%
Male
1
  16.7%
3
  60.0%
4
  36.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 6 participants 5 participants 11 participants
6 5 11
CTAS Score  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Resuscitation
0
   0.0%
0
   0.0%
0
   0.0%
Emergent
0
   0.0%
0
   0.0%
0
   0.0%
Urgent
6
 100.0%
4
  80.0%
10
  90.9%
Semi-Urgent
0
   0.0%
1
  20.0%
1
   9.1%
Non-Urgent
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Pain Intensity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
None
0
   0.0%
0
   0.0%
0
   0.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
2
  33.3%
1
  20.0%
3
  27.3%
Severe
4
  66.7%
4
  80.0%
8
  72.7%
Use of Treatment at Home  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Yes
4
  66.7%
5
 100.0%
9
  81.8%
No
2
  33.3%
0
   0.0%
2
  18.2%
Migraine Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Migraine with aura Number Analyzed 6 participants 5 participants 11 participants
4
  66.7%
5
 100.0%
9
  81.8%
Migraine without aura Number Analyzed 6 participants 5 participants 11 participants
3
  50.0%
0
   0.0%
3
  27.3%
Headache Frequency (Monthly Frequency in Past 3 Months)  
Mean (Standard Deviation)
Unit of measure:  Headaches
Number Analyzed 6 participants 5 participants 11 participants
12.6  (12.9) 7.2  (12.8) 10.3  (12.6)
How Long Participant Has Had Migraines  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 11 participants
5.1  (9.9) 2.0  (1.6) 3.6  (6.8)
PedMIDAS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 6 participants 5 participants 11 participants
58.7  (108.5) 16.2  (17.8) 41  (83.8)
[1]
Measure Description: PedMIDAS: The Pediatric Migraine Disability Assessment Scale measures migraine-specific disability in children and adolescents. The minimum score is 0 and the maximum score is 240. Lower scores indicate less migraine-specific disability and higher scores indicate higher migraine-specific disability. Scores ranging from 0-10 indicate grade I (little-no disability), scores from 11-30 indicate grade II (mild disability), scores from 31-50 indicate grade III (moderate disability) and scores over 50 indicate grade IV (severe disability).
1.Primary Outcome
Title Headache Recurrence at 48 Hours
Hide Description 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).
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
1
  20.0%
2.Secondary Outcome
Title Pain Intensity
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
None
2
  33.3%
1
  20.0%
Mild
2
  33.3%
2
  40.0%
Moderate
2
  33.3%
2
  40.0%
Severe
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Persistent Pain Freedom
Hide Description Persistent 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
Time Frame 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
1
  20.0%
4.Secondary Outcome
Title Patient Satisfaction
Hide Description Patient 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.
Time Frame 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-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
At discharge Satisfied
6
 100.0%
4
  80.0%
Dissatisfied
0
   0.0%
1
  20.0%
At 48 hour follow-up Satisfied
6
 100.0%
4
  80.0%
Dissatisfied
0
   0.0%
1
  20.0%
At 7 day follow-up Satisfied
6
 100.0%
3
  60.0%
Dissatisfied
0
   0.0%
2
  40.0%
5.Secondary Outcome
Title Headache Recurrence at 7 Day Follow-up
Hide Description The proportion of patients in each group with recurrence within the 7 days following ED discharge will be assessed.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Revisits Within 7 Days of Discharge From the ED
Hide Description The number of patients with return ED visits within 7 days of ED discharge will be assessed through chart review.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
0
   0.0%
7.Secondary Outcome
Title Adverse Events at Discharge
Hide Description Adverse 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).
Time Frame 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 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse events
0
   0.0%
0
   0.0%
No adverse events
6
 100.0%
5
 100.0%
8.Secondary Outcome
Title Adverse Events at 48 Hours Post-discharge
Hide Description Adverse 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.
Time Frame 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 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
Worsening headache
1
  16.7%
1
  20.0%
Fever
0
   0.0%
1
  20.0%
Constipation
1
  16.7%
0
   0.0%
No adverse events
4
  66.7%
3
  60.0%
9.Secondary Outcome
Title Adverse Events at 7 Days Post-discharge
Hide Description Adverse 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.
Time Frame 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 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

Overall Number of Participants Analyzed 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
Paresthesias
0
   0.0%
1
  20.0%
Headache recurrence
0
   0.0%
1
  20.0%
No adverse events
6
 100.0%
3
  60.0%
Time Frame Adverse event data were collected at discharge and for the first 7 days after discharge
Adverse Event Reporting Description The medication (dexamethasone) has potential to cause immunosuppression.
 
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

Matched oral solution in same volume per kg as dexamethasone

Placebo: Matched oral solution

All-Cause Mortality
Dexamethasone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Dexamethasone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexamethasone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      3/5 (60.00%)    
Gastrointestinal disorders     
Constipation  1 [1]  1/6 (16.67%)  1 0/5 (0.00%)  0
General disorders     
Fever  1 [2]  0/6 (0.00%)  0 1/5 (20.00%)  1
Nervous system disorders     
Worsening headache  1 [3]  1/6 (16.67%)  1 1/5 (20.00%)  1
Paresthesias  1 [4]  0/6 (0.00%)  0 1/5 (20.00%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
[1]
Patient reporting 3 days with no bowel movement after discharge. The constipation self-resolved.
[2]
One participant had fever post-discharge that resolved
[3]
Patients reporting worsening of their headache post-discharge
[4]
Patient reporting transient self-resolving parenthesis of the upper lip
This study was designed as a pilot trial to assess trial protocol feasibility. Statistical hypothesis testing was not conducted on any of the outcome variables because of the small sample size and the inability to draw inferences from this data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Roger Zemek
Organization: Children's Hospital of Eastern Ontario Research Institute
Phone: 6137377600 ext 3931
EMail: rzemek@cheo.on.ca
Layout table for additonal information
Responsible Party: Roger Zemek, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02794441    
Other Study ID Numbers: 20150453
First Submitted: May 25, 2016
First Posted: June 9, 2016
Results First Submitted: April 30, 2018
Results First Posted: December 3, 2019
Last Update Posted: December 3, 2019