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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.
Perioperative pain management is a significant challenge following surgery. Many pathways contribute to perioperative pain, including nociceptive, inflammatory, and neuropathic sources. Although opioids have long been a mainstay for perioperative analgesia, other non-opioid therapies have been increasingly used as part of a multimodal analgesic regimen to provide improved pain control while minimizing opioid-related side effects
TORADOL (ketorolac tromethamine), is a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level.
Anecdotal evidence has shown that the use of Toradol (Ketorolac) is safe in renal surgery patients. The study team aims to further evaluate this in a pilot study specifically in the population of patient who have donated their kidney in live kidney transplants. The study team will assess how the use of toradol 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. The study team will assess differences in visual analog pain scores and total narcotic consumption, whereas secondary endpoints of urine output, serum creatinine and hemoglobin levels to assess for efficacy and safety.
Pregabalin is prescribed for neuropathic pain. In many studies, preoperative administration of pregabalin reduced postoperative morphine consumption and early postoperative pain.
There will be two arms of the study including:
Arm 1 (pure placebo group): Placebo oral preop then Saline placebo IV x 1 in the OR, then saline placebo IV every 6 hours for 7 doses.
Arm 2: Pregabalin 75mg oral preop, then Ketorolac 30 mg IV x 1 in the OR, then ketorolac 15 mg IV every 6 hours for 7 doses.
Toradol and Lyrica will be used consistent with its FDA approval in terms of dosing, route of administration, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toradol and Lyrica | Experimental | 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). |
|
| Placebo and Standard of Care | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Narcotic Use | 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. | 82.25 hours |
| Length of Hospital Stay | Primary outcomes include length of hospital stay (LOS). | 82.25 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine Levels at One Year Post-operatively | Renal function was evaluated by following serum creatinine levels for up to one year post-operatively. | 1 year |
| Bleeding Risk | Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30589514 | Derived | Campsen J, Call T, Allen CM, Presson AP, Martinez E, Rofaiel G, Kim RD. 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. Am J Transplant. 2019 Jun;19(6):1777-1781. doi: 10.1111/ajt.15242. Epub 2019 Jan 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Narcotic Use | 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. | Posted | Median | Inter-Quartile Range | mg | 82.25 hours |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eryberto Martinez | University of Utah | 801-581-2563 | eddie.martinez@utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2017 | Mar 11, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 3, 2019 | Jul 3, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000069583 | Pregabalin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Pregabalin | Drug | Pregabalin was administered orally: 75 mg 30 minutes prior to operation. |
|
|
| Placebo oral capsule | Drug | Placebo oral capsule was administered orally 30 minutes prior to operation. |
|
| Saline | Drug | Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively. |
|
| 24 hours |
| Number of Patients With Urinary Retention | Patients were evaluated post-operatively during hospital stay for instances of urinary retention. | 82.25 hours |
| 30 Day Mortality | Primary outcomes include 30 day mortality post-operatively. | 30 days |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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. |
|
|
|
| Primary | Length of Hospital Stay | Primary outcomes include length of hospital stay (LOS). | Posted | Median | Inter-Quartile Range | hours | 82.25 hours |
|
|
|
|
| Secondary | Serum Creatinine Levels at One Year Post-operatively | Renal function was evaluated by following serum creatinine levels for up to one year post-operatively. | Posted | Median | Inter-Quartile Range | mg/dL | 1 year |
|
|
|
|
| Secondary | Bleeding Risk | Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss. | Posted | Mean | Standard Deviation | percentage of hematocrit | 24 hours |
|
|
|
|
| Secondary | Number of Patients With Urinary Retention | Patients were evaluated post-operatively during hospital stay for instances of urinary retention. | Posted | Count of Participants | Participants | 82.25 hours |
|
|
|
|
| Secondary | 30 Day Mortality | Primary outcomes include 30 day mortality post-operatively. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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. |