Non-opioids for Analgesia After Adenotonsillectomy in Children
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 300
Summary
- Conditions
- Adenotonsillectomy
- Opioid Use
- Post Operative Analgesia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Experimental, open-label randomized control trial.Masking: None (Open Label)Masking Description: Open labelPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 3 years and 17 years
- Gender
- Both males and females
Description
Purpose: To determine if non-opioid pain control is a safe and effective option in the treatment of post-operative pain following adenotonsillectomy in various pediatric age groups. Methods: The subject population will be patients between the ages of 3 and 17 who will undergo adenotonsillectomy. The...
Purpose: To determine if non-opioid pain control is a safe and effective option in the treatment of post-operative pain following adenotonsillectomy in various pediatric age groups. Methods: The subject population will be patients between the ages of 3 and 17 who will undergo adenotonsillectomy. The study will consist of two unblinded arms - patients receiving standard pain control regimen which include opioids and non-opioids, and patients receiving non-opioid pain medications only. In the diary they will receive, patients or caregivers will record quantity and dosage of pain medication taken each day, a survey, and pain ratings measured by the Wong-Baker FACES Pain Rating Scale. Within 4-8 weeks post-operatively the patients will return for a follow up appointment along with their diary. Demographic information such as age, race, gender, household income will be extracted from the diary and the electronic medical record. Information such as surgical technique, concurrent operations, post-operative pain prescription (types, weight based dosage, and total days prescribed) will be extracted from the electronic medical record and recorded as well. Outcomes measured will include pain scale rating and rates of complications between the two groups. Significance: If it can be demonstrated that non-opioid pain control after adenotonsillectomy does not lead to increased pain or worse outcomes in certain pediatric age groups, a strong argument can be made for the cessation of opioid prescription for these ages following adenotonsillectomy. Given the widespread opioid epidemic, this would be a significant step in curbing the massive opioid problem, as well as reducing the adverse effects of opioid usage in pediatric populations.
Tracking Information
- NCT #
- NCT03618823
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David H Chi, MD Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
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