ConcussionNCT02268058
Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children
A study testing Acetaminophen and Ibuprofen in people with Concussion and Headache, run by McMaster Children's Hospital.
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). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Concussion, Headache
- What is being tested?
- Acetaminophen and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- postive findings on CT scan
- patient with cervical injury
- history of multiple concussions
- positive neurology
About this study
Official title: The Use of Ibuprofen and Acetaminophen for Acute Headache in the Post Concussive Youth: A Pilot Study.
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.
Read the 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
- Being tested
- Acetaminophen, Ibuprofen
- Medical subject headings
- Brain Concussion, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called tylenol
routine administration of medication for a 72 hour period
IbuprofenDrug
Also called advil
routine administration of medication for a 72 hour period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Headache Days
study participants completed a one week diary at home stating if they had headaches.
Measured: one week
Secondary outcomes (1)
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
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Tina Petrelli, McMaster Children's Hospital
- Investigators
- Tina m Petrelli, PhD, Principal investigator, McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268058
- Sponsor's protocol ID
- NIF-Petrelli
- Status last verified
- Oct 2016
- First submitted
- 9 Oct 2014
- Last updated
- 20 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ibuprofen and Acetaminophen for Acute Headache in the Post Concussive Youth: A Pilot Study.
- ClinicalTrials.gov ID
- NCT02268058
- Acronym / sponsor ID
- NIF-Petrelli
- Conditions
- Concussion, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Posted 20 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tx 1: acetaminophen and education | Active comparator | Drug: AcetaminophenPatient 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. |
| Tx 2: ibuprofen and education | Active comparator | Drug: IbuprofenPatient 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. |
| Tx 3: ibuprofen/acetaminophen/education | Active comparator | Drug: Acetaminophen, Drug: IbuprofenPatient 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. |
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- postive findings on CT scan
- patient with cervical injury
- history of multiple concussions
- positive neurology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: tylenolroutine administration of medication for a 72 hour period | Drug | Tx 3: ibuprofen/acetaminophen/education, tx 1: acetaminophen and education |
| IbuprofenAlso: advilroutine administration of medication for a 72 hour period | Drug | Tx 2: ibuprofen and education, Tx 3: ibuprofen/acetaminophen/education |
Primary outcome
Number of Headache Days
Time frame: one week
study participants completed a one week diary at home stating if they had headaches.
1 secondary outcome
Percentage of Study Participants That Returned to School at One Week Post Concussion
Time frame: one week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina m Petrelli, PhD principal investigator
McMaster Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen and Ibuprofen in people with Concussion and Headache, run by McMaster Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Headache Days (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.