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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268058
• Other study ID #: NIF-Petrelli
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: October 19, 2016
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2016
• Source: McMaster Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Concussion
• Headache

Intervention

Drug:
• Acetaminophen
routine administration of medication for a 72 hour period
• Ibuprofen
routine administration of medication for a 72 hour period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	one week	No
Other	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	No
Primary	Number of Headache Days	study participants completed a one week diary at home stating if they had headaches.	one week	No
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	one week	No