Trial Outcomes & Findings for Toradol v. Celecoxib for Postoperative Pain (NCT NCT03331315)

Last Updated: 2023-12-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

170 participants

Primary outcome timeframe

48 hrs following surgery

Results posted on

2023-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	Ketorolac Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Overall Study STARTED	88	82
Overall Study COMPLETED	70	68
Overall Study NOT COMPLETED	18	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketorolac Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Overall Study Physician Decision	18	14

Baseline Characteristics

Toradol v. Celecoxib for Postoperative Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib	Total n=138 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 11.3 • n=5 Participants	55.1 years STANDARD_DEVIATION 14.4 • n=7 Participants	55.7 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	68 Participants n=7 Participants	138 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index	31.8 Kg/m^2 STANDARD_DEVIATION 8.6 • n=5 Participants	31.7 Kg/m^2 STANDARD_DEVIATION 8.1 • n=7 Participants	31.7 Kg/m^2 STANDARD_DEVIATION 8.3 • n=5 Participants
Surgical Pathology Benign	48 Participants n=5 Participants	53 Participants n=7 Participants	101 Participants n=5 Participants
Surgical Pathology Malignant	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Procedure Robotic Assisted Hysterectomy, +/- BSO, Cysto	48 Participants n=5 Participants	53 Participants n=7 Participants	101 Participants n=5 Participants
Procedure Robotic Assisted Hysterectomy, +/- BSO, LND, Cysto	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Operative Time	105 Minutes STANDARD_DEVIATION 32 • n=5 Participants	104 Minutes STANDARD_DEVIATION 34 • n=7 Participants	104 Minutes STANDARD_DEVIATION 33 • n=5 Participants
Trochar Sites	4.3 Trochars STANDARD_DEVIATION 0.5 • n=5 Participants	4.2 Trochars STANDARD_DEVIATION 0.4 • n=7 Participants	4.2 Trochars STANDARD_DEVIATION 0.5 • n=5 Participants
Preoperative Diagnosis Malignancy	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Preoperative Diagnosis Premalignancy	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Preoperative Diagnosis Leiomyoma	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Preoperative Diagnosis Pelvic Pain	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Preoperative Diagnosis Abnormal Uterine Bleeding	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Preoperative Diagnosis Adnexal Mass	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Preoperative Diagnosis Genetic Predisposition to Malignancy	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hrs following surgery

Outcome measures

Outcome measures
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Average Inpatient Postoperative Pain Score	2.7 units on a scale Standard Deviation 1.9	2.4 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 48 hrs following surgery

Average inpatient hydromorphone use measured in milligrams

Outcome measures

Outcome measures
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Average Inpatient Hydromorphone Use	0.7 Milligrams Standard Deviation 1.0	0.8 Milligrams Standard Deviation 1.0

SECONDARY outcome

Timeframe: 48 hrs following surgery

Average inpatient ondansetron use measured in milligrams

Outcome measures

Outcome measures
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Average Inpatient Ondansetron Use	1.5 Milligrams Standard Deviation 1.9	1.3 Milligrams Standard Deviation 2.2

SECONDARY outcome

Timeframe: Following surgery

Total hospital stay from time fo admission to time of discharge measured in hours

Outcome measures

Outcome measures
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Total Hospital Stay	11.6 Hours Standard Error 8.1	11.9 Hours Standard Error 7.6

SECONDARY outcome

Timeframe: During and after surgery

Perioperative Complications measured intraoperatively and postoperatively by type

Outcome measures

Outcome measures
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Number of Participants With Perioperative Complications	5 Patients	6 Patients

SECONDARY outcome

Timeframe: 2 weeks after discharge

Average number of days required for complete return to independent activities of daily living

Outcome measures

Outcome measures
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Return to Activities of Daily Living	2.4 Days Standard Deviation 0.8	2.2 Days Standard Deviation 0.9

SECONDARY outcome

Timeframe: 2 weeks after discharge

Measured using postoperative questionnaire

Outcome measures

Outcome measures
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Days of Oral Narcotic Use After Discharge	5.7 Days Standard Deviation 2.8	3.8 Days Standard Deviation 2.6

SECONDARY outcome

Timeframe: 2 weeks after discharge

Number of oral narcotic pills used after discharge until 2 week postoperative visit.

Outcome measures

Outcome measures
Measure	Ketorolac n=70 Participants Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 Participants Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Number of Oral Narcotic Pills Used After Discharge	8.1 Pills Standard Deviation 4.0	6.0 Pills Standard Deviation 3.6

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Celecoxib

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketorolac n=70 participants at risk Patients receiving scheduled ketorolac postoperatively Ketorolac	Celecoxib n=68 participants at risk Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib
Renal and urinary disorders Acute Kidney Injury	1.4% 1/70 • Number of events 1	0.00% 0/68
Blood and lymphatic system disorders Intraoperative Hemorrhage	0.00% 0/70	2.9% 2/68 • Number of events 2

Additional Information

Michael Ulm

University of Tennessee - West Cancer Center

Phone: 404-281-9480

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place