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

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ClinicalTrials.gov Identifier: NCT03669081
Recruitment Status : Completed
First Posted : September 13, 2018
Results First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Campsen, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition Pain, Postoperative
Interventions Drug: Ketorolac
Drug: Pregabalin
Drug: Placebo oral capsule
Drug: Saline
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 34 30
Completed 33 29
Not Completed 1 1
Reason Not Completed
Data could not be validated             1             1
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 33 29 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  97.0%
27
  93.1%
59
  95.2%
>=65 years
1
   3.0%
2
   6.9%
3
   4.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 29 participants 62 participants
43.8  (11) 45.1  (12.2) 44.4  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
Female
25
  75.8%
17
  58.6%
42
  67.7%
Male
8
  24.2%
12
  41.4%
20
  32.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Cumulative Narcotic Use
Hide Description 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.
Time Frame 82.25 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 33 29
Median (Inter-Quartile Range)
Unit of Measure: mg
27
(13 to 42.3)
45
(25 to 70.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toradol and Lyrica, Placebo and Standard of Care
Comments [Not Specified]
Type of Statistical Test Other
Comments The null hypothesis for the test was no difference between groups.
Statistical Test of Hypothesis P-Value 0.006
Comments The significance level for this test was 0.05.
Method Wilcoxon (Mann-Whitney)
Comments We used an exact Wilcoxon rank sum test due to the skewed nature of the morphine equivalents data and the small sample sizes in each group.
2.Primary Outcome
Title Length of Hospital Stay
Hide Description Primary outcomes include length of hospital stay (LOS).
Time Frame 82.25 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 33 29
Median (Inter-Quartile Range)
Unit of Measure: hours
51.5
(46.5 to 56)
57.3
(50.6 to 66.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toradol and Lyrica, Placebo and Standard of Care
Comments [Not Specified]
Type of Statistical Test Other
Comments The null hypothesis was no difference between groups.
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Exact Wilcoxon rank sum test
Comments [Not Specified]
3.Secondary Outcome
Title Serum Creatinine Levels at One Year Post-operatively
Hide Description Renal function was evaluated by following serum creatinine levels for up to one year post-operatively.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 33 29
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
0.6
(0.6 to 0.7)
0.7
(0.6 to 0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toradol and Lyrica, Placebo and Standard of Care
Comments The safety outcome was used to power our study.To achieve 90% power at a 2.5% significance level for testing that the post-surgery creatinine increase is at most two-fold (where 1.5 fold is expected), or alternatively for the pre-surgery creatinine group to be ≥0.5 times the post-surgery, we need 17 subjects in the toradol group. This calculation was based on a non-inferiority test (one sided t-test) using a coefficient of variation of 0.25 based on preliminary data.
Type of Statistical Test Non-Inferiority
Comments We conducted a 1-sided non-inferiority test using an alpha level of 0.025, for a comparison of the fold change of creatinine levels (pre-operative creatinine/post-operative creatinine) in the Toradol group. Our minimum non-inferiority margin was 0.5, ie the post-operative creatinine level could only increase to at most two times the pre-operative creatinine level.
Statistical Test of Hypothesis P-Value <0.0001
Comments This p-value was compared to a significance threshold of 0.025.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Bleeding Risk
Hide Description Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: percentage of hematocrit
6.3  (2.1) 4.3  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toradol and Lyrica, Placebo and Standard of Care
Comments [Not Specified]
Type of Statistical Test Other
Comments The null hypothesis was no difference between groups.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients With Urinary Retention
Hide Description Patients were evaluated post-operatively during hospital stay for instances of urinary retention.
Time Frame 82.25 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toradol and Lyrica, Placebo and Standard of Care
Comments [Not Specified]
Type of Statistical Test Other
Comments The null hypothesis was no difference between groups.
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title 30 Day Mortality
Hide Description Primary outcomes include 30 day mortality post-operatively.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Toradol and Lyrica Placebo and Standard of Care
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Toradol and Lyrica Placebo and Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/29 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Toradol and Lyrica Placebo and Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Toradol and Lyrica Placebo and Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/29 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Eryberto Martinez
Organization: University of Utah
Phone: 801-581-2563
EMail: eddie.martinez@utah.edu
Layout table for additonal information
Responsible Party: Jeffrey Campsen, University of Utah
ClinicalTrials.gov Identifier: NCT03669081     History of Changes
Other Study ID Numbers: 00094756
First Submitted: September 11, 2018
First Posted: September 13, 2018
Results First Submitted: April 15, 2019
Results First Posted: August 15, 2019
Last Update Posted: August 15, 2019