Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04112160
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 8.9

Study Details

Study Description

Brief Summary

This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.

Condition or Disease	Intervention/Treatment	Phase
Pain; Urinary Stone; Urinary Calculi	Drug: Ketorolac; Drug: normal saline	Phase 2

Detailed Description

Patients who are undergoing cystoscopy with ureteral stent removal at the University of Texas Southwestern Medical Center and have no contraindications to receiving ketorolac will be eligible. Patients will be randomized to receive either a 1 mL injection of ketorolac tromethamine or 1 mL injection of normal saline (0.9%) as the control arm. Ketorolac is a member of the pyrrolo-pyrrole group of non steroid anti inflammatory drugs. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The peak analgesic effect occurs within 2-3 hours. If no contraindications exist, ketorolac can be safely given to patients of any age in the 30 mg intramuscular formulation if given as a one time dose according to the package insert.

Normal saline contains 0.9% of Sodium chloride in each mL. Like ketorolac, it is a clear solution and given that there are no major side effects of normal saline it is a good control for our study. It is packaged in a single dose vial that contains 100 mL. It is preservative free and stored at room temperature (20-25°C). Local pain at the injection site may occur, temporarily.

The investigators will specifically look at pain scores before and after stent removal as well as narcotic medication use, telephone calls and/or emergency room visits for pain. Based on the rate of renal colic from our quality improvement project and prior work, the investigators calculated the maximum number of local subjects to be consented for this study to be n=116 (see biostatistics section). The study is expected to last 6 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
• Actual Study Start Date: Jun 28, 2018
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control normal saline 0.9%	Drug: normal saline; normal saline; Other Names: Placebo
Active Comparator: Ketorolac 30 mg of Ketorolac	Drug: Ketorolac; IM injection of either normal saline or Ketorolac; Other Names: Toradol

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Unscheduled Return to Clinic or Emergency Room [Seven days following ureteral stent removal.]

   Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal.

2. Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal [Twenty-four hours following ureteral stent removal.]

   Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal.

3. Number of Participants That Experienced an Injection Complication [Within thirty days post injection.]

   Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication.

4. Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal. [Seven days following ureteral stent removal.]

   Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal.

Secondary Outcome Measures

1. Number of Patients That Required Opioid Medication Following Ureteral Stent Removal [Twenty-four hours following stent removal.]

   Determine the use of opioid medications in morphine equivalents in the 24 hours following stent removal.

2. Average Number of Days the Participant Missed Work [Seven days following stent removal.]

   Determine amount of missed work or school due to renal colic following ureteral stent removal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral stent placement at Clements University Hospital and are presenting to the office for cystoscopy and stent removal.

Exclusion Criteria:

• eGFR <50

• any active or history of peptic ulcer disease or GI bleeding

• Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis

• Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or heparin

• Allergic reaction to NSAIDs

• Concurrent use of other NSAIDs within 24 hours

• Pregnancy (ketorolac contraindicated in this population)

• Recent myocardial infarction (MI)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Margaret Pearle, MD.PhD, UT Southwestern Medical Center

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jun 9, 2020

More Information

Publications

None provided.

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT04112160
• Other Study ID Numbers: STU 012018-080
• First Posted: Oct 2, 2019
• Last Update Posted: Jul 22, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of Texas Southwestern Medical Center: stent removal, pain, kidney stones
• Additional relevant MeSH terms: Urinary Calculi; Urolithiasis; Calculi; Ketorolac

Study Results

Participant Flow

Arm/Group Title	Control	Ketorolac
Arm/Group Description	normal saline 0.9% normal saline: normal saline	30 mg of Ketorolac Ketorolac: IM injection of either normal saline or Ketorolac
Period Title: Overall Study
STARTED	63	62
COMPLETED	62	62
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Control	Ketorolac	Total
Arm/Group Description	normal saline 0.9%	30 mg of Ketorolac	Total of all reporting groups
Overall Participants	63	62	125
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	47 74.6%	46 74.2%	93 74.4%
>=65 years	16 25.4%	16 25.8%	32 25.6%
Age (Years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Years]	57	54	56
Sex: Female, Male (Count of Participants)
Female	28 44.4%	31 50%	59 47.2%
Male	35 55.6%	31 50%	66 52.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 3.2%	1 1.6%	3 2.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 7.9%	8 12.9%	13 10.4%
White	56 88.9%	53 85.5%	109 87.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	63 100%	62 100%	125 100%
Visual Analog Pain (VAS) Pain Scale at the baseline (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	1	2	2

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Unscheduled Return to Clinic or Emergency Room
Description	Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal.
Time Frame	Seven days following ureteral stent removal.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	normal saline 0.9%	30 mg of Ketorolac
Measure Participants	62	62
Count of Participants [Participants]	8 12.7%	1 1.6%

2. Primary Outcome

Title	Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal
Description	Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal.
Time Frame	Twenty-four hours following ureteral stent removal.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	normal saline 0.9%	30 mg of Ketorolac
Measure Participants	62	62
Median (Inter-Quartile Range) [score on a scale]	2	1

3. Primary Outcome

Title	Number of Participants That Experienced an Injection Complication
Description	Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication.
Time Frame	Within thirty days post injection.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	normal saline 0.9%	30 mg of Ketorolac
Measure Participants	62	62
Count of Participants [Participants]	1 1.6%	1 1.6%

4. Primary Outcome

Title	Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal.
Description	Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal.
Time Frame	Seven days following ureteral stent removal.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	normal saline 0.9%	30 mg of Ketorolac
Measure Participants	62	62
Median (Inter-Quartile Range) [score on a scale (0-10, 0= no pain)]	0	0

5. Secondary Outcome

Title	Number of Patients That Required Opioid Medication Following Ureteral Stent Removal
Description	Determine the use of opioid medications in morphine equivalents in the 24 hours following stent removal.
Time Frame	Twenty-four hours following stent removal.

Outcome Measure Data

Analysis Population Description

Number of patients that had any opioid use at 24 hours post stent removal.

Arm/Group Title	Control	Ketorolac
Arm/Group Description	normal saline 0.9%	30 mg of Ketorolac
Measure Participants	62	62
Count of Participants [Participants]	17 27%	17 27.4%

6. Secondary Outcome

Title	Average Number of Days the Participant Missed Work
Description	Determine amount of missed work or school due to renal colic following ureteral stent removal.
Time Frame	Seven days following stent removal.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	normal saline 0.9%	30 mg of Ketorolac
Measure Participants	62	62
Mean (Standard Deviation) [days of missed work]	2.3 (3.7)	2.7 (4.2)

Adverse Events

Time Frame	11 months
Arm/Group Title	Control		Ketorolac
Arm/Group Description	normal saline 0.9%		30 mg of Ketorolac
All Cause Mortality
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/62 (0%)
Serious Adverse Events
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/62 (0%)

Limitations/Caveats

There are inherent variations in the size/location of nephrolithiasis, surgical/stent parameters, and patient characteristics that cannot be be defined or controlled.

More Information

Certain Agreements

All Principal Investigators ARE 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.