NCT03331315: POP

Toradol v. Celecoxib for Postoperative Pain

Completed Phase 2 Results posted Last updated 7 December 2023

What this trial tests

Phase 2 trial testing Celecoxib in Pain, Postoperative in 170 participants. Completed in 1 January 2017.

Timeline

1 September 2013

Primary endpoint
30 June 2016

1 January 2017

Quick facts

Lead sponsor	Michael Ulm, MD
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	170
Start date	1 September 2013
Primary completion	30 June 2016
Estimated completion	1 January 2017
Sites	1 location across United States

Drugs / interventions tested

• Celecoxib (celecoxib) — full drug profile →
• Ketorolac (KETOROLAC) — full drug profile →

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Michael Ulm, MD

Who can join

18 and older, female only, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Inpatient Postoperative Pain Score Primary · 48 hrs following surgery

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.

Group	Value	95% CI
Ketorolac	2.7	± 1.9
Celecoxib	2.4	± 1.6

Average Inpatient Hydromorphone Use Secondary · 48 hrs following surgery

Average inpatient hydromorphone use measured in milligrams

Group	Value	95% CI
Ketorolac	0.7	± 1.0
Celecoxib	0.8	± 1.0

Average Inpatient Ondansetron Use Secondary · 48 hrs following surgery

Average inpatient ondansetron use measured in milligrams

Group	Value	95% CI
Ketorolac	1.5	± 1.9
Celecoxib	1.3	± 2.2

Total Hospital Stay Secondary · Following surgery

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

Group	Value	95% CI
Ketorolac	11.6	± 8.1
Celecoxib	11.9	± 7.6

Number of Participants With Perioperative Complications Secondary · During and after surgery

Perioperative Complications measured intraoperatively and postoperatively by type

Group	Value	95% CI
Ketorolac	5
Celecoxib	6

Return to Activities of Daily Living Secondary · 2 weeks after discharge

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

Group	Value	95% CI
Ketorolac	2.4	± 0.8
Celecoxib	2.2	± 0.9

Days of Oral Narcotic Use After Discharge Secondary · 2 weeks after discharge

Measured using postoperative questionnaire

Group	Value	95% CI
Ketorolac	5.7	± 2.8
Celecoxib	3.8	± 2.6

Number of Oral Narcotic Pills Used After Discharge Secondary · 2 weeks after discharge

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

Group	Value	95% CI
Ketorolac	8.1	± 4.0
Celecoxib	6.0	± 3.6

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ketorolac

Serious: 0/70 (0%)

Deaths: —

Celecoxib

Serious: 0/68 (0%)

Deaths: —

Other adverse events (2 terms — click to expand)

Reaction	System	Ketorolac	Celecoxib
Intraoperative Hemorrhage	Blood and lymphatic system disorders	—	—
Acute Kidney Injury	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT03331315 adverse events section.

Sponsor's own description

Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single-dose intravenous ketorolac for acute postoperative pain in adults.
   McNicol ED, Ferguson MC, Schumann R. · · 2021 · cited 19× · PMID 33998669 · DOI 10.1002/14651858.cd013263.pub2