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

NCT02268058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-10-20

Study results available
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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.

Conditions

Interventions

DRUG

Acetaminophen

routine administration of medication for a 72 hour period

DRUG

Ibuprofen

routine administration of medication for a 72 hour period

Sponsors & Collaborators

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Tina m Petrelli, PhD · McMaster Children's Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2014-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02268058 on ClinicalTrials.gov