Post-operative Pain Control After Pediatric Adenotonsillectomy
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|ClinicalTrials.gov Identifier: NCT02296840|
Recruitment Status : Terminated
First Posted : November 20, 2014
Results First Posted : March 27, 2018
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Tonsillitis Obstructive Sleep Apnea Sleep Disordered Breathing Adverse Reaction to Drug||Drug: Ibuprofen Drug: Hydrocodone-Acetaminophen||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparing Narcotics With Non-steroidal Anti-inflammatory Drugs (NSAIDS) Post-operatively in Pediatric Patients Undergoing Adenotonsillectomy|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 30, 2016|
|Actual Study Completion Date :||November 30, 2016|
After undergoing adenotonsillectomy, patients who are randomized into the test intervention arm will receive ibuprofen (10mg/kg/day every 6-8 hours) after surgery.
Ibuprofen 10mg/kg/day every 6-8 hours
Active Comparator: Hydrocodone-acetaminophen (Control)
After undergoing adenotonsillectomy, patients who are randomized into the control intervention will receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours).
Hydrocodone-Acetaminophen 0.15mg/kg/day every 4-6 hours
- Faces Pain Score [ Time Frame: 2 weeks after surgery ]Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores could range from 0 to 980.
- Number of Participants With Post-operative Bleeding [ Time Frame: 2 weeks after surgery ]The occurrence of post-operative bleeding at the surgical site for each participant will be assessed by review of the participant's study records and clinical records and by questioning the caregiver in follow-up. If postoperative bleeding has occurred, details of the episode of bleeding will also be obtained (requirement for surgical intervention, observation at home, or observation at the hospital).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296840
|United States, Georgia|
|Children's Healthcare of Atlanta (CHOA)|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Roy Rajan, MD||Emory University|