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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
Sponsor:
Information provided by (Responsible Party):
Roy Rajan, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Recurrent Tonsillitis
Obstructive Sleep Apnea
Sleep Disordered Breathing
Adverse Reaction to Drug
Interventions Drug: Ibuprofen
Drug: Hydrocodone-Acetaminophen
Enrollment 45

Recruitment Details Participants were recruited between November 2014 and February 2016.
Pre-assignment Details Eight of the 53 individuals who consented to taking part in the study did not meet eligibility criteria, resulting in 45 participants who began the intervention.
Arm/Group Title Ibuprofen Hydrocodone-acetaminophen
Hide Arm/Group Description Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy. Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Period Title: Overall Study
Started 18 27
Completed 9 8
Not Completed 9 19
Reason Not Completed
Adverse Event             1             1
Protocol Violation             2             1
Lost to Follow-up             6             17
Arm/Group Title Ibuprofen Hydrocodone-acetaminophen Total
Hide Arm/Group Description Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy. Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy. Total of all reporting groups
Overall Number of Baseline Participants 18 27 45
Hide Baseline Analysis Population Description
Children undergoing tonsillectomy who met all eligibility criteria and enrolled in the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 27 participants 45 participants
<=18 years
18
 100.0%
27
 100.0%
45
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 27 participants 45 participants
Female
9
  50.0%
10
  37.0%
19
  42.2%
Male
9
  50.0%
17
  63.0%
26
  57.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 27 participants 45 participants
18
 100.0%
27
 100.0%
45
 100.0%
1.Primary Outcome
Title Faces Pain Score
Hide Description 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.
Time Frame 2 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Children who returned the completed the survey at two weeks post-surgery.
Arm/Group Title Ibuprofen Hydrocodone-acetaminophen
Hide Arm/Group Description:
Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
158.95  (9.33) 219.94  (21.43)
2.Secondary Outcome
Title Number of Participants With Post-operative Bleeding
Hide Description 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).
Time Frame 2 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All study participants are included in this analysis.
Arm/Group Title Ibuprofen Hydrocodone-acetaminophen
Hide Arm/Group Description:
Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Overall Number of Participants Analyzed 18 27
Measure Type: Count of Participants
Unit of Measure: Participants
2
  11.1%
0
   0.0%
Time Frame Adverse event data were collected for two weeks following surgery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibuprofen Hydrocodone-acetaminophen
Hide Arm/Group Description Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy. Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
All-Cause Mortality
Ibuprofen Hydrocodone-acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ibuprofen Hydrocodone-acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      0/27 (0.00%)    
Metabolism and nutrition disorders     
Hospitalization due to low oral intake and dehydration *  1/18 (5.56%)  1 0/27 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ibuprofen Hydrocodone-acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      1/27 (3.70%)    
Surgical and medical procedures     
Emergency room visit due to bleeding *  1/18 (5.56%)  1 0/27 (0.00%)  0
Emergency room visit due to pain *  0/18 (0.00%)  0 1/27 (3.70%)  1
*
Indicates events were collected by non-systematic assessment
Many participants did not completed the pain control survey, limiting the conclusions that can be made from this study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Roy Rajan, MD
Organization: Emory University
Phone: 404-778-2400
Responsible Party: Roy Rajan, Emory University
ClinicalTrials.gov Identifier: NCT02296840     History of Changes
Other Study ID Numbers: IRB00070851
First Submitted: November 18, 2014
First Posted: November 20, 2014
Results First Submitted: February 26, 2018
Results First Posted: March 27, 2018
Last Update Posted: April 25, 2018