NCT03669081

Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy

Completed Phase 2 Results posted Last updated 15 August 2019

What this trial tests

Phase 2 trial testing Ketorolac in Pain, Postoperative in 64 participants. Completed in 30 September 2018.

Timeline

20 September 2016

Primary endpoint
30 September 2018

30 September 2018

Quick facts

Lead sponsor	University of Utah
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	64
Start date	20 September 2016
Primary completion	30 September 2018
Estimated completion	30 September 2018

Drugs / interventions tested

• Ketorolac (KETOROLAC) — full drug profile →
• Pregabalin (Pregabalin) — full drug profile →
• Placebo oral capsule
• Saline

Conditions studied

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

Sponsor

University of Utah

Who can join

18 and older, any sex, 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.

Cumulative Narcotic Use Primary · 82.25 hours

Cumulative narcotic use was defined by cumulative morphine equivalents over the course of a patient's hospital course. The Washington State Agency Medical Director's Group Opioid dose calculator was used to provide a total morphine dose equivalent (MDE) for each patient while in the hospital.

Group	Value	95% CI
Toradol and Lyrica	27	13 – 42.3
Placebo and Standard of Care	45	25 – 70.8

Length of Hospital Stay Primary · 82.25 hours

Primary outcomes include length of hospital stay (LOS).

Group	Value	95% CI
Toradol and Lyrica	51.5	46.5 – 56
Placebo and Standard of Care	57.3	50.6 – 66.3

Serum Creatinine Levels at One Year Post-operatively Secondary · 1 year

Renal function was evaluated by following serum creatinine levels for up to one year post-operatively.

Group	Value	95% CI
Toradol and Lyrica	0.6	0.6 – 0.7
Placebo and Standard of Care	0.7	0.6 – 0.7

Bleeding Risk Secondary · 24 hours

Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss.

Group	Value	95% CI
Toradol and Lyrica	6.3	± 2.1
Placebo and Standard of Care	4.3	± 2.5

Number of Patients With Urinary Retention Secondary · 82.25 hours

Patients were evaluated post-operatively during hospital stay for instances of urinary retention.

Group	Value	95% CI
Toradol and Lyrica	1
Placebo and Standard of Care	0

30 Day Mortality Secondary · 30 days

Primary outcomes include 30 day mortality post-operatively.

Group	Value	95% CI
Toradol and Lyrica	0
Placebo and Standard of Care	0

Sponsor's own description

The investigators will assess how the use of toradol and pregabalin affects return to bowel function and see if there is a difference in length of hospital stay. Narcotic use can affect bowel function so the investigators hypothesize that use of Toradol will decrease delayed bowel function and aid in a patients discharge and reduction of hospital stay.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospective, double-blind, randomized clinical trial comparing an ERAS pathway with ketorolac and pregabalin versus standard of care plus placebo during live donor nephrectomy for kidney transplant.
   Campsen J, Call T, Allen CM, Presson AP, et al · · 2019 · cited 25× · PMID 30589514 · DOI 10.1111/ajt.15242
2. One-Year Post Hoc Analysis of Renal Function for Live Kidney Donors That Were Enrolled in an Enhanced Recovery After Surgery Pathway With Ketorolac.
   Campsen J, Zhang C, Presson A, Goodale M, et al · · 2020 · cited 3× · PMID 32999779 · DOI 10.7759/cureus.10056