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N/A N=80 Randomized

Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children

Concussion · Headache

Enrolled (actual)
80
Serious AEs
Results posted
Oct 2016
Primary outcome: Primary: Number of Headache Days — 4; 3; 3; 4 number of headache days

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Acetaminophen (Drug); Ibuprofen (Drug)
Age
Pediatric, Adult · 8+ yrs
Sex
All
Sponsor
McMaster Children's Hospital
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Headache Days
4; 3; 3; 4
SECONDARY
Percentage of Study Participants That Returned to School at One Week Post Concussion
33; 61; 79; 21

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02268058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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