Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.

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Detailed Description

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Conditions

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Renal Calculus Kidney Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketorolac

90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Placebo

1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Interventions

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Ketorolac

90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Intervention Type DRUG

Placebo

1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Intervention Type DRUG

Other Intervention Names

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Toradol Acular

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing percutaneous nephrolithotomy for kidney stone disease

Exclusion Criteria

* History of nonsteroidal antiinflammatory drug allergy
* Asthma
* History of long-term opioid use
* Intraoperative blood loss greater than 300 mL
* Postoperative hemodynamic instability
* Active peptic ulcer disease
* Advanced renal impairment (Creatinine \> 2.0 mg/dL)
* Bleeding diathesis
* Current use of probenecid
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No