Trial Outcomes & Findings for Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy (NCT NCT03669081)

NCT ID: NCT03669081

Last Updated: 2019-08-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: 82.25 hours
• Results posted on: 2019-08-15

Participant Flow

Participant milestones

Measure	Toradol and Lyrica Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Overall Study STARTED	34	30
Overall Study COMPLETED	33	29
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Toradol and Lyrica Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Overall Study Data could not be validated	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Toradol and Lyrica n=33 Participants Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care n=29 Participants Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=33 Participants	0 Participants n=29 Participants	0 Participants n=62 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=33 Participants	27 Participants n=29 Participants	59 Participants n=62 Participants
Age, Categorical >=65 years	1 Participants n=33 Participants	2 Participants n=29 Participants	3 Participants n=62 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 11 • n=33 Participants	45.1 years STANDARD_DEVIATION 12.2 • n=29 Participants	44.4 years STANDARD_DEVIATION 11.4 • n=62 Participants
Sex: Female, Male Female	25 Participants n=33 Participants	17 Participants n=29 Participants	42 Participants n=62 Participants
Sex: Female, Male Male	8 Participants n=33 Participants	12 Participants n=29 Participants	20 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Toradol and Lyrica n=33 Participants Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care n=29 Participants Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Cumulative Narcotic Use	27 mg Interval 13.0 to 42.3	45 mg Interval 25.0 to 70.8

PRIMARY outcome

Timeframe: 82.25 hours

Primary outcomes include length of hospital stay (LOS).

Outcome measures

Measure	Toradol and Lyrica n=33 Participants Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care n=29 Participants Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Length of Hospital Stay	51.5 hours Interval 46.5 to 56.0	57.3 hours Interval 50.6 to 66.3

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Toradol and Lyrica n=33 Participants Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care n=29 Participants Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Serum Creatinine Levels at One Year Post-operatively	0.6 mg/dL Interval 0.6 to 0.7	0.7 mg/dL Interval 0.6 to 0.7

SECONDARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Toradol and Lyrica n=33 Participants Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care n=29 Participants Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Bleeding Risk	6.3 percentage of hematocrit Standard Deviation 2.1	4.3 percentage of hematocrit Standard Deviation 2.5

SECONDARY outcome

Timeframe: 82.25 hours

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

Outcome measures

Measure	Toradol and Lyrica n=33 Participants Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care n=29 Participants Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Number of Patients With Urinary Retention	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Primary outcomes include 30 day mortality post-operatively.

Outcome measures

Measure	Toradol and Lyrica n=33 Participants Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge). Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation.	Placebo and Standard of Care n=29 Participants Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained. Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation. Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
30 Day Mortality	0 Participants	0 Participants

Adverse Events

Toradol and Lyrica

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo and Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eryberto Martinez

University of Utah

Phone: 801-581-2563

Email: eddie.martinez@utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place