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

NCT ID: NCT02268058

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-05-31

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.

Detailed 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.

Conditions

Concussion; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

tx 1: acetaminophen and education

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.

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

routine administration of medication for a 72 hour period

Tx 2: ibuprofen and education

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.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

routine administration of medication for a 72 hour period

Tx 3: ibuprofen/acetaminophen/education

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.

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

routine administration of medication for a 72 hour period

Ibuprofen

Intervention Type: DRUG

routine administration of medication for a 72 hour period

Tx 4: no routine meds and education

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acetaminophen

routine administration of medication for a 72 hour period

Intervention Type: DRUG

Ibuprofen

routine administration of medication for a 72 hour period

Intervention Type: DRUG

Other Intervention Names

tylenol; advil

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr.Tina Petrelli

McMaster Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tina m Petrelli, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster Children's Hospital

Other Identifiers

NIF-Petrelli

Identifier Type: -

Identifier Source: org_study_id