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Completed

NCT Number: NCT02268058

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

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.

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Key information

Conditions

Concussion Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Headache Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

routine administration of medication for a 72 hour period

Other names: tylenol

Ibuprofen

Drug

routine administration of medication for a 72 hour period

Other names: advil

Primary outcomes

  1. Number of Headache Days

    Time frame: one week

    study participants completed a one week diary at home stating if they had headaches.

Secondary outcomes

  1. Percentage of Study Participants That Returned to School at One Week Post Concussion

    Time frame: one week

    patients/family were asked if the child returned to school one week after their injury

Other outcomes

  1. Headache Intensity Per Day for One Week

    Time frame: 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.

  2. Number of Headaches a Day

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McMaster Children's Hospital

Other

Registry information

Official study title

The Use of Ibuprofen and Acetaminophen for Acute Headache in the Post Concussive Youth: A Pilot Study.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 20, 2014
Registry last updated
Oct 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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