Concussion, Headache
Conditions
Brief summary
Concussions and headache are a significant problem for children and athletes. While headache generally resolves within 7-10 days; a significant proportion of children, 72-93% experience prolonged headache as a symptom of Post Concussion Syndrome (PCS). The prevailing clinical view is that mild head injuries resolve with little chance of complications. However, the reality is quite different. Concussion in children presents with a range of severity and results in both short and long-term physical, cognitive, emotional and behavioural sequelae known as PCS with varying times to resolution. To date there are no specific treatments for headache pain related to concussion. Physical and cognitive rest is the mainstay of initial concussion management. The number of children presenting to ED's with a history of concussion and headache is increasing. Presently there are no evidence based guidelines available to guide the medical team to effectively and consistently manage their headache. Our present standard of care is based on the CANCHILD concussion guidelines outlining the child's return to school and activity. Yet, our present standard of treatment is compromised and somewhat counterproductive if we are not treating the child's headache pain. Our pilot study ' An Open Label Randomized Control Pilot Study Examining Treatment of Headache In The Post-Concussive Youth' showed that routine administration of oral analgesia improves the child's headache symptoms and helps with school re-entry one week post injury, compared to a standard care group defined as non routine administration of pain medications.
Detailed description
Objective Post Injury concussion and headache are problematic for children after mild traumatic brain injuries. There are no evidence based guidelines for the management of acute post concussive headache. The objectives of this study were to assess the efficacy of routine administration of analgesia on concussion headache and classify headaches using the IHS criteria. Method A 4 arm open label pilot RCT study was conducted. The treatment arms were: (i) acetaminophen,(ii) ibuprofen, (iii) acetaminophen and ibuprofen and (iv) a standard control group. Eight to eighteen year olds presenting to emergency with headache 24-48 hours after their first concussion were recruited consecutively and sequentially randomized. Demographic data was collected, headache survey administered and standard concussion education given. Headaches were diarized over one week capturing the (i) number of headaches, (ii) headache days,(iii) headache intensity and (iv) return to school.
Interventions
DRUGAcetaminophen
routine administration of medication for a 72 hour period
DRUGIbuprofen
routine administration of medication for a 72 hour period
Sponsors
McMaster Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with a first time concussion * english speaking * presenting to Emergency with headache 24-48 hours post concussion * normal Glascow Coma Scale * 8-18 years of age
Exclusion criteria
* postive findings on CT scan * patient with cervical injury * history of multiple concussions * positive neurology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Headache Days | one week | study participants completed a one week diary at home stating if they had headaches. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Study Participants That Returned to School at One Week Post Concussion | one week | patients/family were asked if the child returned to school one week after their injury |
Other
| Measure | Time frame | Description |
|---|---|---|
| Headache Intensity Per Day for One Week | one week | The 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. |
| Number of Headaches a Day | one week | the patient family were given a headache diary and instruction to document the number of headaches they have a day for a one week period. |
Participant flow
Recruitment details
Youth presenting to pediatric tertiary centre ED within 48 hours of concussive event and having headache.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| 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 | 20 |
| 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. | 20 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Tx 2: Ibuprofen and Education | Tx 3: Ibuprofen/Acetaminophen/Education | tx 1: Acetaminophen and Education | Tx 4: no Routine Meds and Education | Total |
|---|---|---|---|---|---|
| Age, Continuous | 13.0 years STANDARD_DEVIATION 2.6 | 12.3 years STANDARD_DEVIATION 3 | 14.1 years STANDARD_DEVIATION 2.2 | 12.3 years STANDARD_DEVIATION 2.4 | 13.1 years STANDARD_DEVIATION 2.6 |
| mechanism of injury assault | 2 participants | 0 participants | 1 participants | 0 participants | 3 participants |
| mechanism of injury fall | 6 participants | 4 participants | 3 participants | 5 participants | 18 participants |
| mechanism of injury motor vehicle accident | 0 participants | 0 participants | 2 participants | 1 participants | 3 participants |
| mechanism of injury other | 0 participants | 3 participants | 2 participants | 2 participants | 7 participants |
| mechanism of injury sports | 12 participants | 13 participants | 12 participants | 12 participants | 49 participants |
| Region of Enrollment Canada | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 14 Participants | 8 Participants | 9 Participants | 9 Participants | 40 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 11 Participants | 11 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Headache Days
study participants completed a one week diary at home stating if they had headaches.
Time frame: one week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| tx 1: Acetaminophen and Education | Number of Headache Days | 4 number of headache days |
| Tx 2: Ibuprofen and Education | Number of Headache Days | 3 number of headache days |
| Tx 3: Ibuprofen/Acetaminophen/Education | Number of Headache Days | 3 number of headache days |
| Tx 4: no Routine Meds and Education | Number of Headache Days | 4 number of headache days |
Secondary
Percentage of Study Participants That Returned to School at One Week Post Concussion
patients/family were asked if the child returned to school one week after their injury
Time frame: one week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| tx 1: Acetaminophen and Education | Percentage of Study Participants That Returned to School at One Week Post Concussion | 33 percentage of participants |
| Tx 2: Ibuprofen and Education | Percentage of Study Participants That Returned to School at One Week Post Concussion | 61 percentage of participants |
| Tx 3: Ibuprofen/Acetaminophen/Education | Percentage of Study Participants That Returned to School at One Week Post Concussion | 79 percentage of participants |
| Tx 4: no Routine Meds and Education | Percentage of Study Participants That Returned to School at One Week Post Concussion | 21 percentage of participants |
Other Pre-specified
Headache Intensity Per Day for One Week
The 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.
Time frame: one week
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| tx 1: Acetaminophen and Education | Headache Intensity Per Day for One Week | day five n=18, n=3, n=0, n=20 | 4 units on a scale |
| tx 1: Acetaminophen and Education | Headache Intensity Per Day for One Week | day two n=19, n=20, n=20, n=20 | 6 units on a scale |
| tx 1: Acetaminophen and Education | Headache Intensity Per Day for One Week | day 6 n=12, n=0, n=0, n=20, | 4 units on a scale |
| tx 1: Acetaminophen and Education | Headache Intensity Per Day for One Week | day 4 n=19, n=18, n=4, n=20 | 5 units on a scale |
| tx 1: Acetaminophen and Education | Headache Intensity Per Day for One Week | day 3 n=19, n= 20, n=20, n=20 | 5 units on a scale |
| tx 1: Acetaminophen and Education | Headache Intensity Per Day for One Week | day one n=19, n=20, n= 20, n=20 | 8 units on a scale |
| tx 1: Acetaminophen and Education | Headache Intensity Per Day for One Week | day 7 n=4, n=0, n=0, n=18 | 3.5 units on a scale |
| Tx 2: Ibuprofen and Education | Headache Intensity Per Day for One Week | day 3 n=19, n= 20, n=20, n=20 | 4 units on a scale |
| Tx 2: Ibuprofen and Education | Headache Intensity Per Day for One Week | day 4 n=19, n=18, n=4, n=20 | 3 units on a scale |
| Tx 2: Ibuprofen and Education | Headache Intensity Per Day for One Week | day five n=18, n=3, n=0, n=20 | 3 units on a scale |
| Tx 2: Ibuprofen and Education | Headache Intensity Per Day for One Week | day 6 n=12, n=0, n=0, n=20, | NA units on a scale |
| Tx 2: Ibuprofen and Education | Headache Intensity Per Day for One Week | day 7 n=4, n=0, n=0, n=18 | NA units on a scale |
| Tx 2: Ibuprofen and Education | Headache Intensity Per Day for One Week | day one n=19, n=20, n= 20, n=20 | 8 units on a scale |
| Tx 2: Ibuprofen and Education | Headache Intensity Per Day for One Week | day two n=19, n=20, n=20, n=20 | 6 units on a scale |
| Tx 3: Ibuprofen/Acetaminophen/Education | Headache Intensity Per Day for One Week | day 6 n=12, n=0, n=0, n=20, | NA units on a scale |
| Tx 3: Ibuprofen/Acetaminophen/Education | Headache Intensity Per Day for One Week | day two n=19, n=20, n=20, n=20 | 5 units on a scale |
| Tx 3: Ibuprofen/Acetaminophen/Education | Headache Intensity Per Day for One Week | day 7 n=4, n=0, n=0, n=18 | NA units on a scale |
| Tx 3: Ibuprofen/Acetaminophen/Education | Headache Intensity Per Day for One Week | day 4 n=19, n=18, n=4, n=20 | 2.5 units on a scale |
| Tx 3: Ibuprofen/Acetaminophen/Education | Headache Intensity Per Day for One Week | day one n=19, n=20, n= 20, n=20 | 7 units on a scale |
| Tx 3: Ibuprofen/Acetaminophen/Education | Headache Intensity Per Day for One Week | day five n=18, n=3, n=0, n=20 | NA units on a scale |
| Tx 3: Ibuprofen/Acetaminophen/Education | Headache Intensity Per Day for One Week | day 3 n=19, n= 20, n=20, n=20 | 3 units on a scale |
| Tx 4: no Routine Meds and Education | Headache Intensity Per Day for One Week | day 6 n=12, n=0, n=0, n=20, | 5 units on a scale |
| Tx 4: no Routine Meds and Education | Headache Intensity Per Day for One Week | day 4 n=19, n=18, n=4, n=20 | 6 units on a scale |
| Tx 4: no Routine Meds and Education | Headache Intensity Per Day for One Week | day one n=19, n=20, n= 20, n=20 | 8 units on a scale |
| Tx 4: no Routine Meds and Education | Headache Intensity Per Day for One Week | day 3 n=19, n= 20, n=20, n=20 | 6 units on a scale |
| Tx 4: no Routine Meds and Education | Headache Intensity Per Day for One Week | day 7 n=4, n=0, n=0, n=18 | 5 units on a scale |
| Tx 4: no Routine Meds and Education | Headache Intensity Per Day for One Week | day five n=18, n=3, n=0, n=20 | 5 units on a scale |
| Tx 4: no Routine Meds and Education | Headache Intensity Per Day for One Week | day two n=19, n=20, n=20, n=20 | 8 units on a scale |
Other Pre-specified
Number of Headaches a Day
the patient family were given a headache diary and instruction to document the number of headaches they have a day for a one week period.
Time frame: one week
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| tx 1: Acetaminophen and Education | Number of Headaches a Day | day one n=19, n=20, n= 20, n=20 | 4 headaches per day |
| tx 1: Acetaminophen and Education | Number of Headaches a Day | day 6 n=12, n=0, n=0, n=20, | 2 headaches per day |
| tx 1: Acetaminophen and Education | Number of Headaches a Day | day four n=18, n=3, n=0, n=20 | 3 headaches per day |
| tx 1: Acetaminophen and Education | Number of Headaches a Day | day two n=19, n=20, n=20, n=20 | 4 headaches per day |
| tx 1: Acetaminophen and Education | Number of Headaches a Day | day 7 n=4, n=0, n=0, n=18 | 1 headaches per day |
| tx 1: Acetaminophen and Education | Number of Headaches a Day | day 3 n=19, n= 20, n=20, n=20 | 3 headaches per day |
| tx 1: Acetaminophen and Education | Number of Headaches a Day | day 4 n=19, n=18, n=4, n=20 | 3 headaches per day |
| Tx 2: Ibuprofen and Education | Number of Headaches a Day | day 6 n=12, n=0, n=0, n=20, | NA headaches per day |
| Tx 2: Ibuprofen and Education | Number of Headaches a Day | day 4 n=19, n=18, n=4, n=20 | 2 headaches per day |
| Tx 2: Ibuprofen and Education | Number of Headaches a Day | day 3 n=19, n= 20, n=20, n=20 | 3 headaches per day |
| Tx 2: Ibuprofen and Education | Number of Headaches a Day | day four n=18, n=3, n=0, n=20 | 1 headaches per day |
| Tx 2: Ibuprofen and Education | Number of Headaches a Day | day 7 n=4, n=0, n=0, n=18 | NA headaches per day |
| Tx 2: Ibuprofen and Education | Number of Headaches a Day | day two n=19, n=20, n=20, n=20 | 3 headaches per day |
| Tx 2: Ibuprofen and Education | Number of Headaches a Day | day one n=19, n=20, n= 20, n=20 | 3 headaches per day |
| Tx 3: Ibuprofen/Acetaminophen/Education | Number of Headaches a Day | day 4 n=19, n=18, n=4, n=20 | 1 headaches per day |
| Tx 3: Ibuprofen/Acetaminophen/Education | Number of Headaches a Day | day one n=19, n=20, n= 20, n=20 | 3 headaches per day |
| Tx 3: Ibuprofen/Acetaminophen/Education | Number of Headaches a Day | day two n=19, n=20, n=20, n=20 | 2 headaches per day |
| Tx 3: Ibuprofen/Acetaminophen/Education | Number of Headaches a Day | day 3 n=19, n= 20, n=20, n=20 | 2 headaches per day |
| Tx 3: Ibuprofen/Acetaminophen/Education | Number of Headaches a Day | day four n=18, n=3, n=0, n=20 | NA headaches per day |
| Tx 3: Ibuprofen/Acetaminophen/Education | Number of Headaches a Day | day 6 n=12, n=0, n=0, n=20, | NA headaches per day |
| Tx 3: Ibuprofen/Acetaminophen/Education | Number of Headaches a Day | day 7 n=4, n=0, n=0, n=18 | NA headaches per day |
| Tx 4: no Routine Meds and Education | Number of Headaches a Day | day 3 n=19, n= 20, n=20, n=20 | 4 headaches per day |
| Tx 4: no Routine Meds and Education | Number of Headaches a Day | day 7 n=4, n=0, n=0, n=18 | 3 headaches per day |
| Tx 4: no Routine Meds and Education | Number of Headaches a Day | day 6 n=12, n=0, n=0, n=20, | 3 headaches per day |
| Tx 4: no Routine Meds and Education | Number of Headaches a Day | day two n=19, n=20, n=20, n=20 | 4 headaches per day |
| Tx 4: no Routine Meds and Education | Number of Headaches a Day | day one n=19, n=20, n= 20, n=20 | 4 headaches per day |
| Tx 4: no Routine Meds and Education | Number of Headaches a Day | day four n=18, n=3, n=0, n=20 | 4 headaches per day |
| Tx 4: no Routine Meds and Education | Number of Headaches a Day | day 4 n=19, n=18, n=4, n=20 | 4 headaches per day |