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

NCT02268058 | Completed Results

• 1 other identifier: NIF-Petrelli
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Concussion; Headache

Outcome Measures

Primary Outcomes (1)

• Number of Headache Days

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

  one week

Secondary Outcomes (1)

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

  one week

Other Outcomes (2)

• Headache Intensity Per Day for One Week

  one week

• Number of Headaches a Day

  one week

Study Arms (4)

tx 1: acetaminophen and education

ACTIVE COMPARATOR

Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week. Patient and family received standard education on concussion management in the Emergency department.

Drug: Acetaminophen

Tx 2: ibuprofen and education

ACTIVE COMPARATOR

Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week. Patient and family received standard education on concussion management in the Emergency department.

Drug: Ibuprofen

Tx 3: ibuprofen/acetaminophen/education

ACTIVE COMPARATOR

Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week. Patient and family received standard education on concussion management in the Emergency Department.

Drug: Acetaminophen; Drug: Ibuprofen

Tx 4: no routine meds and education

NO INTERVENTION

Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen. The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period.

Interventions

Acetaminophen DRUG

routine administration of medication for a 72 hour period

Also known as: tylenol

Tx 3: ibuprofen/acetaminophen/education; tx 1: acetaminophen and education

Ibuprofen DRUG

routine administration of medication for a 72 hour period

Also known as: advil

Tx 2: ibuprofen and education; Tx 3: ibuprofen/acetaminophen/education

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosed with a first time concussion
• english speaking
• presenting to Emergency with headache 24-48 hours post concussion
• normal Glascow Coma Scale
• years of age

You may not qualify if:

• postive findings on CT scan
• patient with cervical injury
• history of multiple concussions
• positive neurology

Sponsors & Collaborators

• McMaster Children's Hospital: lead

MeSH Terms

Conditions

Brain Concussion; Headache

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

open label study, not blinded pilot study, no sample size calculation

Results Point of Contact

• Title: Dr. Tina Petrelli
• Organization: McMaster Children's Hospital

petrelli@hhsc.ca

905-521-2100

Study Officials

• Tina m Petrelli, PhD

  McMaster Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: McMaster Children's Hospital

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 20, 2016
• Results First Posted: October 20, 2016

Record last verified: 2016-10