Clinical trial NCT02268058: Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children
Official title: The Use of Ibuprofen and Acetaminophen for Acute Headache in the Post Concussive Youth: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion
Headache
Lead sponsor: McMaster Children's Hospital
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Headache Days
timeFrame: one week
Secondary outcomes:
measure: Percentage of Study Participants That Returned to School at One Week Post Concussion
timeFrame: one week
Other outcomes:
measure: Headache Intensity Per Day for One Week
timeFrame: one week
measure: Number of Headaches a Day
timeFrame: one week
Locations:
Study officials:
affiliation: McMaster Children's Hospital
name: Tina m Petrelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: