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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tx 1: acetaminophen and education | Active Comparator | 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. |
|
| Tx 2: ibuprofen and education | Active Comparator | 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. |
|
| Tx 3: ibuprofen/acetaminophen/education | Active Comparator | 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. |
|
| Tx 4: no routine meds and education | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | routine administration of medication for a 72 hour period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Headache Days | study participants completed a one week diary at home stating if they had headaches. | one week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tina m Petrelli, PhD | McMaster Children's Hospital | Principal Investigator |
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Youth presenting to pediatric tertiary centre ED within 48 hours of concussive event and having headache.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Headache Days | study participants completed a one week diary at home stating if they had headaches. | Posted | Mean | Full Range | number of headache days | one week |
|
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serious and other adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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open label study, not blinded pilot study, no sample size calculation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tina Petrelli | McMaster Children's Hospital | 905-521-2100 | 75162 | petrelli@hhsc.ca |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D006261 | Headache |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Ibuprofen | Drug | routine administration of medication for a 72 hour period |
|
|
| one week |
| 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. | one week |
| BG001 |
| 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 |
| BG002 | 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 |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| mechanism of injury | Number | participants |
|
| OG002 | 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 |
| OG003 | 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. |
|
|
| 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 | Posted | Number | percentage of participants | one week |
|
|
|
| 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. | Posted | Median | Full Range | units on a scale | one week |
|
|
|
| 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. | Posted | Median | Full Range | headaches per day | one week |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| day two n=19, n=20, n=20, n=20 |
|
| day 3 n=19, n= 20, n=20, n=20 |
|
| day 4 n=19, n=18, n=4, n=20 |
|
| day five n=18, n=3, n=0, n=20 |
|
| day 6 n=12, n=0, n=0, n=20, |
|
| day 7 n=4, n=0, n=0, n=18 |
|
| day two n=19, n=20, n=20, n=20 |
|
| day 3 n=19, n= 20, n=20, n=20 |
|
| day 4 n=19, n=18, n=4, n=20 |
|
| day four n=18, n=3, n=0, n=20 |
|
| day 6 n=12, n=0, n=0, n=20, |
|
| day 7 n=4, n=0, n=0, n=18 |
|