Pain at Home After Tonsillectomy With or Without Adenoidectomy (NCT03378830) | Clinical Trial Compass
CompletedNot Applicable
Pain at Home After Tonsillectomy With or Without Adenoidectomy
Canada319 participantsStarted 2017-12-19
Plain-language summary
The study type is a prospective observational cohort study of children undergoing adenotonsillectomy (T\&A). The study will recruit the annual caseload of children undergoing T\&A at the Montreal Children's Hospital, QC, Canada; aiming for 200 children. There are no interventions.
The purpose of this study is to determine the severity and duration of postoperative pain after T\&A and to link the severity of this pain with the severity of sleep disordered breathing.
Who can participate
Age range
2 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Elective scheduled surgery for adenotonsillectomy
* Fluency in French
* Fluency in English
Exclusion Criteria:
* Neuromuscular disease
* Seizure disorders,
* Cyanotic heart disease,
* Trisomy 21,
* Craniofacial syndromes such as Crouzons syndrome,
* Steroid dependant asthma,
* Cystic fibrosis,
* Bronchopulmonary dysplasia
* Severe autism .
* Developmental delay which impair the assessment of pain.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Parent Pain Measure (PPPM)
Timeframe: We are asking the parents to record the PPPM twice daily for 14 days.
Trial details
NCT IDNCT03378830
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre