Trial Outcomes & Findings for Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children (NCT NCT02268058)
NCT ID: NCT02268058
Last Updated: 2016-10-20
Results Overview
study participants completed a one week diary at home stating if they had headaches.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
one week
Results posted on
2016-10-20
Participant Flow
Youth presenting to pediatric tertiary centre ED within 48 hours of concussive event and having headache.
Participant milestones
| Measure |
tx 1: Acetaminophen and Education
Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period
|
Tx 2: Ibuprofen and Education
Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 3: Ibuprofen/Acetaminophen/Education
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 4: no Routine Meds and Education
Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
tx 1: Acetaminophen and Education
Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period
|
Tx 2: Ibuprofen and Education
Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 3: Ibuprofen/Acetaminophen/Education
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 4: no Routine Meds and Education
Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children
Baseline characteristics by cohort
| Measure |
tx 1: Acetaminophen and Education
n=20 Participants
Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period
|
Tx 2: Ibuprofen and Education
n=20 Participants
Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 3: Ibuprofen/Acetaminophen/Education
n=20 Participants
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 4: no Routine Meds and Education
n=20 Participants
Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 2.2 • n=93 Participants
|
13.0 years
STANDARD_DEVIATION 2.6 • n=4 Participants
|
12.3 years
STANDARD_DEVIATION 3.0 • n=27 Participants
|
12.3 years
STANDARD_DEVIATION 2.4 • n=483 Participants
|
13.1 years
STANDARD_DEVIATION 2.6 • n=36 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
20 participants
n=27 Participants
|
20 participants
n=483 Participants
|
80 participants
n=36 Participants
|
|
mechanism of injury
fall
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
4 participants
n=27 Participants
|
5 participants
n=483 Participants
|
18 participants
n=36 Participants
|
|
mechanism of injury
sports
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
13 participants
n=27 Participants
|
12 participants
n=483 Participants
|
49 participants
n=36 Participants
|
|
mechanism of injury
motor vehicle accident
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
3 participants
n=36 Participants
|
|
mechanism of injury
assault
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
3 participants
n=36 Participants
|
|
mechanism of injury
other
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
3 participants
n=27 Participants
|
2 participants
n=483 Participants
|
7 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: one weekstudy participants completed a one week diary at home stating if they had headaches.
Outcome measures
| Measure |
tx 1: Acetaminophen and Education
n=19 Participants
Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period
|
Tx 2: Ibuprofen and Education
n=20 Participants
Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 3: Ibuprofen/Acetaminophen/Education
n=20 Participants
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 4: no Routine Meds and Education
n=20 Participants
Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period.
|
|---|---|---|---|---|
|
Number of Headache Days
|
4 number of headache days
Interval 2.0 to 5.0
|
3 number of headache days
Interval 3.0 to 4.0
|
3 number of headache days
Interval 2.0 to 4.0
|
4 number of headache days
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: one weekpatients/family were asked if the child returned to school one week after their injury
Outcome measures
| Measure |
tx 1: Acetaminophen and Education
n=19 Participants
Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period
|
Tx 2: Ibuprofen and Education
n=20 Participants
Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 3: Ibuprofen/Acetaminophen/Education
n=20 Participants
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 4: no Routine Meds and Education
n=20 Participants
Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period.
|
|---|---|---|---|---|
|
Percentage of Study Participants That Returned to School at One Week Post Concussion
|
33 percentage of participants
|
61 percentage of participants
|
79 percentage of participants
|
21 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one weekThe Numerical Rating Scale (NRS) will be used to capture the intensity of the headache experience. The NRS was initially developed for acute post procedural pain and is now a common measure for headache and disease related pain with well established reliability and validity as a self report measure in this age group. Children meeting the inclusion criteria also meet the criteria for self report. The numerical rating scale includes indicators from 0 to 10 with 0 being the 'no pain' and 10 being 'the worst pain ever'. The child when diarizing the headaches will report a pain intensity score for each headache type in their one week headache diary. Study participants and their parent will be given instruction regarding reporting the headache instruction. The headache intensity scores were averaged for the day per participant.
Outcome measures
| Measure |
tx 1: Acetaminophen and Education
n=19 Participants
Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period
|
Tx 2: Ibuprofen and Education
n=20 Participants
Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 3: Ibuprofen/Acetaminophen/Education
n=20 Participants
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 4: no Routine Meds and Education
n=20 Participants
Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period.
|
|---|---|---|---|---|
|
Headache Intensity Per Day for One Week
day one n=19, n=20, n= 20, n=20
|
8 units on a scale
Interval 6.0 to 9.0
|
8 units on a scale
Interval 6.0 to 9.0
|
7 units on a scale
Interval 4.0 to 8.0
|
8 units on a scale
Interval 6.0 to 9.0
|
|
Headache Intensity Per Day for One Week
day two n=19, n=20, n=20, n=20
|
6 units on a scale
Interval 5.0 to 7.0
|
6 units on a scale
Interval 4.0 to 6.0
|
5 units on a scale
Interval 2.0 to 6.0
|
8 units on a scale
Interval 6.0 to 9.0
|
|
Headache Intensity Per Day for One Week
day 3 n=19, n= 20, n=20, n=20
|
5 units on a scale
Interval 4.0 to 6.0
|
4 units on a scale
Interval 3.0 to 5.0
|
3 units on a scale
Interval 2.0 to 4.0
|
6 units on a scale
Interval 4.0 to 8.0
|
|
Headache Intensity Per Day for One Week
day 4 n=19, n=18, n=4, n=20
|
5 units on a scale
Interval 3.0 to 6.0
|
3 units on a scale
Interval 2.0 to 4.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
6 units on a scale
Interval 4.0 to 7.0
|
|
Headache Intensity Per Day for One Week
day five n=18, n=3, n=0, n=20
|
4 units on a scale
Interval 3.0 to 6.0
|
3 units on a scale
Interval 2.0 to 3.0
|
NA units on a scale
no headaches reported
|
5 units on a scale
Interval 5.0 to 7.0
|
|
Headache Intensity Per Day for One Week
day 6 n=12, n=0, n=0, n=20,
|
4 units on a scale
Interval 3.0 to 5.0
|
NA units on a scale
no headaches reported
|
NA units on a scale
no headaches reported
|
5 units on a scale
Interval 4.0 to 7.0
|
|
Headache Intensity Per Day for One Week
day 7 n=4, n=0, n=0, n=18
|
3.5 units on a scale
Interval 3.0 to 6.0
|
NA units on a scale
no headaches reported
|
NA units on a scale
no headaches reported
|
5 units on a scale
Interval 3.0 to 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one weekthe patient family were given a headache diary and instruction to document the number of headaches they have a day for a one week period.
Outcome measures
| Measure |
tx 1: Acetaminophen and Education
n=19 Participants
Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period
|
Tx 2: Ibuprofen and Education
n=20 Participants
Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 3: Ibuprofen/Acetaminophen/Education
n=20 Participants
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period
|
Tx 4: no Routine Meds and Education
n=20 Participants
Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period.
|
|---|---|---|---|---|
|
Number of Headaches a Day
day 7 n=4, n=0, n=0, n=18
|
1 headaches per day
Interval 1.0 to 1.0
|
NA headaches per day
no headaches reported
|
NA headaches per day
no headaches reported
|
3 headaches per day
Interval 1.0 to 4.0
|
|
Number of Headaches a Day
day one n=19, n=20, n= 20, n=20
|
4 headaches per day
Interval 2.0 to 5.0
|
3 headaches per day
Interval 3.0 to 4.0
|
3 headaches per day
Interval 2.0 to 4.0
|
4 headaches per day
Interval 4.0 to 6.0
|
|
Number of Headaches a Day
day two n=19, n=20, n=20, n=20
|
4 headaches per day
Interval 3.0 to 4.0
|
3 headaches per day
Interval 3.0 to 4.0
|
2 headaches per day
Interval 2.0 to 4.0
|
4 headaches per day
Interval 3.0 to 5.0
|
|
Number of Headaches a Day
day 3 n=19, n= 20, n=20, n=20
|
3 headaches per day
Interval 2.0 to 4.0
|
3 headaches per day
Interval 2.0 to 3.0
|
2 headaches per day
Interval 1.0 to 3.0
|
4 headaches per day
Interval 3.0 to 5.0
|
|
Number of Headaches a Day
day 4 n=19, n=18, n=4, n=20
|
3 headaches per day
Interval 2.0 to 4.0
|
2 headaches per day
Interval 1.0 to 3.0
|
1 headaches per day
Interval 1.0 to 1.0
|
4 headaches per day
Interval 3.0 to 5.0
|
|
Number of Headaches a Day
day four n=18, n=3, n=0, n=20
|
3 headaches per day
Interval 1.0 to 4.0
|
1 headaches per day
Interval 1.0 to 1.0
|
NA headaches per day
no headaches reported
|
4 headaches per day
Interval 3.0 to 4.0
|
|
Number of Headaches a Day
day 6 n=12, n=0, n=0, n=20,
|
2 headaches per day
Interval 1.0 to 3.0
|
NA headaches per day
no headaches reported
|
NA headaches per day
no headaches reported
|
3 headaches per day
Interval 1.0 to 5.0
|
Adverse Events
tx 1: Acetaminophen and Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tx 2: Ibuprofen and Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tx 3: Ibuprofen/Acetaminophen/Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tx 4: no Routine Meds and Education
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