Trial · NCT02268058
Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children
NCT02268058, Not applicable, Completed, McMaster Children's Hospital; results first posted 2016-10-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children. Trials, record NCT02268058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02268058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children
- NCT number
- NCT02268058
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 80 participants, actual
- Lead sponsor
- McMaster Children's Hospital
- Conditions
- Concussion, Headache
- Interventions
- Acetaminophen, Ibuprofen
- First posted
- 2014-10-20
- Last updated
- 2016-10-20
- Results first posted
- 2016-10-20
- Limitations and caveats
- open label study, not blinded pilot study, no sample size calculation
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Headache Days | one week | study participants completed a one week diary at home stating if they had headaches. |
| Secondary | Percentage of Study Participants That Returned to School at One Week Post Concussion | one week | patients/family were asked if the child returned to school one week after their injury |
| Other | Headache Intensity Per Day for One Week | 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. |
| Other | Number of Headaches a Day | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Headache Days | one week | number of headache days | MEAN | |
| SECONDARY | Percentage of Study Participants That Returned to School at One Week Post Concussion | one week | percentage of participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Headache Intensity Per Day for One Week | one week | units on a scale | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Headaches a Day | one week | headaches per day | MEDIAN |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Headache Days | tx 1: Acetaminophen and Education | 4 | Full Range 2 to 5 | number of headache days | |
| Number of Headache Days | Tx 2: Ibuprofen and Education | 3 | Full Range 3 to 4 | number of headache days | |
| Number of Headache Days | Tx 3: Ibuprofen/Acetaminophen/Education | 3 | Full Range 2 to 4 | number of headache days | |
| Number of Headache Days | Tx 4: no Routine Meds and Education | 4 | Full Range 4 to 6 | number of headache days | |
| Percentage of Study Participants That Returned to School at One Week Post Concussion | tx 1: Acetaminophen and Education | 33 | percentage of participants | ||
| Percentage of Study Participants That Returned to School at One Week Post Concussion | Tx 2: Ibuprofen and Education | 61 | percentage of participants | ||
| Percentage of Study Participants That Returned to School at One Week Post Concussion | Tx 3: Ibuprofen/Acetaminophen/Education | 79 | percentage of participants | ||
| Percentage of Study Participants That Returned to School at One Week Post Concussion | Tx 4: no Routine Meds and Education | 21 | percentage of participants | ||
| Headache Intensity Per Day for One Week | tx 1: Acetaminophen and Education | day one n=19, n=20, n= 20, n=20 | 8 | Full Range 6 to 9 | units on a scale |
| Headache Intensity Per Day for One Week | Tx 2: Ibuprofen and Education | day one n=19, n=20, n= 20, n=20 | 8 | Full Range 6 to 9 | units on a scale |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | tx 1: Acetaminophen and Education | 20 | |
| Overall Study | STARTED | Tx 2: Ibuprofen and Education | 20 | |
| Overall Study | STARTED | Tx 3: Ibuprofen/Acetaminophen/Education | 20 | |
| Overall Study | STARTED | Tx 4: no Routine Meds and Education | 20 | |
| Overall Study | COMPLETED | tx 1: Acetaminophen and Education | 19 | |
| Overall Study | COMPLETED | Tx 2: Ibuprofen and Education | 20 | |
| Overall Study | COMPLETED | Tx 3: Ibuprofen/Acetaminophen/Education | 20 | |
| Overall Study | COMPLETED | Tx 4: no Routine Meds and Education | 20 | |
| Overall Study | NOT COMPLETED | tx 1: Acetaminophen and Education | 1 | |
| Overall Study | NOT COMPLETED | Tx 2: Ibuprofen and Education | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | tx 1: Acetaminophen and Education | ||
| Total, all-cause mortality | Tx 2: Ibuprofen and Education | ||
| Total, all-cause mortality | Tx 3: Ibuprofen/Acetaminophen/Education | ||
| Total, all-cause mortality | Tx 4: no Routine Meds and Education | ||
| Total, other adverse events | tx 1: Acetaminophen and Education | 0 | 0 |
| Total, other adverse events | Tx 2: Ibuprofen and Education | 0 | 0 |
| Total, other adverse events | Tx 3: Ibuprofen/Acetaminophen/Education | 0 | 0 |
| Total, other adverse events | Tx 4: no Routine Meds and Education | 0 | 0 |
| Total, serious adverse events | tx 1: Acetaminophen and Education | 0 | 0 |
| Total, serious adverse events | Tx 2: Ibuprofen and Education | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02268058
GET https://conductscience.org/api/trials/v1/NCT02268058/results?page=2