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Celecoxib as a Post-tonsillectomy Pain Medication

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Douglas J Van Daele, University of Iowa
ClinicalTrials.gov Identifier:
NCT00583453
First received: December 20, 2007
Last updated: February 12, 2017
Last verified: February 2017
Results First Received: February 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Tonsillitis
Interventions: Drug: Celecoxib
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Celecoxib as Experimerimental Intervention

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo Control, Active Comparator

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery


Participant Flow:   Overall Study
    Celecoxib as Experimerimental Intervention   Placebo Control, Active Comparator
STARTED   9   8 
COMPLETED   9   6 
NOT COMPLETED   0   2 
discontinued intervention                0                2 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Celecoxib 200 mg Tablets

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo With Same Dosing Schedule as the Active Comparator Arm

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Total Total of all reporting groups

Baseline Measures
   Celecoxib 200 mg Tablets   Placebo With Same Dosing Schedule as the Active Comparator Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   8   17 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      9 100.0%      8 100.0%      17 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.1  (4.1)   25.0  (3.3)   25.0  (3.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  88.9%      7  87.5%      15  88.2% 
Male      1  11.1%      1  12.5%      2  11.8% 
Region of Enrollment 
[Units: Participants]
     
United States   9   8   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Self-reported Pain Score   [ Time Frame: day of procedure through post-operative day 10 ]

2.  Secondary:   Self-reported Activity Level   [ Time Frame: From operative day through 10 days post-operative ]

3.  Secondary:   Acetaminophen Equivalent Use   [ Time Frame: From operative day through 10 days post-operative ]

4.  Secondary:   Incidence of Post-operative Hemorrhage   [ Time Frame: From operative day through 10 days post-operative ]

5.  Secondary:   Total Morphine Equivalent   [ Time Frame: From operative day through 10 days post-operative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Small sample size Disproportionately female population


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Douglas Van Daele
Organization: University of Iowa
phone: 319-353-8162
e-mail: douglas-van-daele@uiowa.edu


Publications of Results:

Responsible Party: Douglas J Van Daele, University of Iowa
ClinicalTrials.gov Identifier: NCT00583453     History of Changes
Other Study ID Numbers: 200703765
Study First Received: December 20, 2007
Results First Received: February 12, 2017
Last Updated: February 12, 2017