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Trial record 49 of 145 for:    Hydrocodone

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between November 2014 and February 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Ibuprofen Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
Hydrocodone-acetaminophen Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.

Participant Flow:   Overall Study
    Ibuprofen   Hydrocodone-acetaminophen
STARTED   18   27 
COMPLETED   9   8 
NOT COMPLETED   9   19 
Adverse Event                1                1 
Protocol Violation                2                1 
Lost to Follow-up                6                17 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Children undergoing tonsillectomy who met all eligibility criteria and enrolled in the study.

Reporting Groups
  Description
Ibuprofen Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
Hydrocodone-acetaminophen Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Total Total of all reporting groups

Baseline Measures
   Ibuprofen   Hydrocodone-acetaminophen   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   27   45 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      9  50.0%      10  37.0%      19  42.2% 
Male      9  50.0%      17  63.0%      26  57.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   18   27   45 


  Outcome Measures

1.  Primary:   Faces Pain Score   [ Time Frame: 2 weeks after surgery ]

2.  Secondary:   Number of Participants With Post-operative Bleeding   [ Time Frame: 2 weeks after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Many participants did not completed the pain control survey, limiting the conclusions that can be made from this study.


  More Information

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
e-mail: royrajan@yahoo.com


Publications:

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