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Toradol v. Celecoxib for Postoperative Pain (POP)

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ClinicalTrials.gov Identifier: NCT03331315
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : June 4, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Ulm, University of Tennessee Health Science Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: Celecoxib
Drug: Ketorolac
Enrollment 170
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Period Title: Overall Study
Started 88 82
Completed 70 68
Not Completed 18 14
Reason Not Completed
Physician Decision             18             14
Arm/Group Title Ketorolac Celecoxib Total
Hide Arm/Group Description

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Total of all reporting groups
Overall Number of Baseline Participants 70 68 138
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 68 participants 138 participants
56.3  (11.3) 55.1  (14.4) 55.7  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 68 participants 138 participants
Female
70
 100.0%
68
 100.0%
138
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 70 participants 68 participants 138 participants
31.8  (8.6) 31.7  (8.1) 31.7  (8.3)
Surgical Pathology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 68 participants 138 participants
Benign
48
  68.6%
53
  77.9%
101
  73.2%
Malignant
22
  31.4%
15
  22.1%
37
  26.8%
Procedure   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 68 participants 138 participants
Robotic Assisted Hysterectomy, +/- BSO, Cysto
48
  68.6%
53
  77.9%
101
  73.2%
Robotic Assisted Hysterectomy, +/- BSO, LND, Cysto
22
  31.4%
15
  22.1%
37
  26.8%
[1]
Measure Description: BSO - bilateral salpingo-oophorectomy LND - Lymph Node Dissection Cysto - diagnostic cystoscopy
Operative Time  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 70 participants 68 participants 138 participants
105  (32) 104  (34) 104  (33)
Trochar Sites  
Mean (Standard Deviation)
Unit of measure:  Trochars
Number Analyzed 70 participants 68 participants 138 participants
4.3  (0.5) 4.2  (0.4) 4.2  (0.5)
Preoperative Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 68 participants 138 participants
Malignancy
21
  30.0%
15
  22.1%
36
  26.1%
Premalignancy
14
  20.0%
15
  22.1%
29
  21.0%
Leiomyoma
8
  11.4%
4
   5.9%
12
   8.7%
Pelvic Pain
11
  15.7%
8
  11.8%
19
  13.8%
Abnormal Uterine Bleeding
3
   4.3%
8
  11.8%
11
   8.0%
Adnexal Mass
10
  14.3%
14
  20.6%
24
  17.4%
Genetic Predisposition to Malignancy
3
   4.3%
4
   5.9%
7
   5.1%
1.Primary Outcome
Title Average Inpatient Postoperative Pain Score
Hide Description Pain measured using the Visual Analog Scale, no pain (0–0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5–7.4 cm), and severe pain (7.5–10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff.
Time Frame 48 hrs following surgery
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Celecoxib
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Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Overall Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (1.9) 2.4  (1.6)
2.Secondary Outcome
Title Average Inpatient Hydromorphone Use
Hide Description Average inpatient hydromorphone use measured in milligrams
Time Frame 48 hrs following surgery
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description:

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Overall Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: Milligrams
0.7  (1.0) 0.8  (1.0)
3.Secondary Outcome
Title Average Inpatient Ondansetron Use
Hide Description Average inpatient ondansetron use measured in milligrams
Time Frame 48 hrs following surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description:

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Overall Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: Milligrams
1.5  (1.9) 1.3  (2.2)
4.Secondary Outcome
Title Total Hospital Stay
Hide Description Total hospital stay from time fo admission to time of discharge measured in hours
Time Frame Following surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description:

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Overall Number of Participants Analyzed 70 68
Mean (Standard Error)
Unit of Measure: Hours
11.6  (8.1) 11.9  (7.6)
5.Secondary Outcome
Title Number of Participants With Perioperative Complications
Hide Description Perioperative Complications measured intraoperatively and postoperatively by type
Time Frame During and after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description:
Participants
Participants
Overall Number of Participants Analyzed 70 68
Measure Type: Number
Unit of Measure: Patients
5 6
6.Secondary Outcome
Title Return to Activities of Daily Living
Hide Description Average number of days required for complete return to independent activities of daily living
Time Frame 2 weeks after discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description:

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Overall Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: Days
2.4  (0.8) 2.2  (0.9)
7.Secondary Outcome
Title Days of Oral Narcotic Use After Discharge
Hide Description Measured using postoperative questionnaire
Time Frame 2 weeks after discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description:

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Overall Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: Days
5.7  (2.8) 3.8  (2.6)
8.Secondary Outcome
Title Number of Oral Narcotic Pills Used After Discharge
Hide Description Number of oral narcotic pills used after discharge until 2 week postoperative visit.
Time Frame 2 weeks after discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description:

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

Overall Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: Pills
8.1  (4.0) 6.0  (3.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Celecoxib
Hide Arm/Group Description

Patients receiving scheduled ketorolac postoperatively

Ketorolac

Patients receiving celebrex preoperative and postoperatively for 7 days

Celecoxib

All-Cause Mortality
Ketorolac Celecoxib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Celecoxib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/68 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketorolac Celecoxib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/70 (1.43%)      2/68 (2.94%)    
Blood and lymphatic system disorders     
Intraoperative Hemorrhage * [1]  0/70 (0.00%)  0 2/68 (2.94%)  2
Renal and urinary disorders     
Acute Kidney Injury * [2]  1/70 (1.43%)  1 0/68 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Estimated Blood Loss >150cc
[2]
Transient acute kidney injury, resolved with IV hydration
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: Michael Ulm
Organization: University of Tennessee - West Cancer Center
Phone: 404-281-9480
Responsible Party: Michael Ulm, University of Tennessee Health Science Center
ClinicalTrials.gov Identifier: NCT03331315     History of Changes
Other Study ID Numbers: 12-02041-FB
First Submitted: April 7, 2015
First Posted: November 6, 2017
Results First Submitted: March 29, 2018
Results First Posted: June 4, 2018
Last Update Posted: June 29, 2018