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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2019-08-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain Urinary Stone Urinary Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control

normal saline 0.9%

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

normal saline

Ketorolac

30 mg of Ketorolac

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

IM injection of either normal saline or Ketorolac

Interventions

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Ketorolac

IM injection of either normal saline or Ketorolac

Intervention Type DRUG

normal saline

Intervention Type DRUG

Other Intervention Names

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Toradol Placebo

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No