Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT02638506
Eligibility Criteria:
Inclusion Criteria:
\- Inclusion criteria will consist of children aged eight to 18 years who present to the pediatric ED with a chief complaint of headaches, regardless of the type, with a moderate or severe pain score.
Pain was considered at least moderate if superior or equal to 36 mm on the VAS as demonstrated by Hirschfeld et. Al. This level have been chosen because it has been recognized that adequate sensitivity in analgesia trials for acute pain can only be obtained if patients experience at least moderate pain before administration of any treatment.
Exclusion Criteria:
* 1\. Allergy or any contra-indication to opioids and-or ibuprofen 2. Previous participation in study to preserve the statistic independence of each participant 3. Caregiver unable to provide consent (language barrier or lack of caregiver presence) 4. Circumstance which, in the opinion of the investigator, would adversely affect their participation in the trial such as a medical or psychiatric condition or a language barrier (neither French or English) 5. Nasopharyngeal anomalies, blockage or traumatized preventing nasal administration 6. Suspicion of life-threatening illness such as acute intracranial haemorrhage, meningitis, encephalopathy, or intracranial cerebral vascular occlusion 7. Signs of intracranial pressure or suspicion of intracerebral process such as mass or tumors (altered mental status, focal neurological deficit, etc.) 8. Any head injury with possible associate intracranial injury in the past 14 daysRecent or acute head injury 9. Current opioid use or opioid antagonist use 10. Intoxication
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT02638506
Study Brief:
Protocol Section:
NCT02638506