Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

Phase 4

• Conditions: Renal Colic
• Interventions: Drug: Ketorolac and nefopam balanced analgesia; Drug: Balanced analgesia using ketorolac and morphine; Drug: Pain control with single analgesics (ketorolac)

• Registration Number: NCT01543165
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.

Detailed Description

The balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. Previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. We hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Status Verified: 2012-12
• Study Start: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Acute flank with visual analog pain scale score equal or more than 5
• and most possible diagnosis after initial clinical exam is acute renal colic

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Exclusion Criteria

• Pregnant or lactating women
• Patients whose use of any of the study drugs is contraindicated
• Patients with documented renal or hepatic failure or those with clinical findings suggesting the diagnoses
• Recent episode of acute myocardial infarction or patients with significant heart failure
• Patients with documented gastric/duodenal ulcer or those with clinical findings suggesting the diagnoses
• Patients with bleeding tendency
• Patients who have history of any seizure
• Patients with documented organic brain injury
• Patients taking warfarin
• Patients whose primary diagnosis is not renal colic

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Ketorolac and nefopam balanced analgesia	Sequential intravenous administration of ketorolac and nefopam
Group 2	Balanced analgesia using ketorolac and morphine	Sequential intravenous administration of ketorolac and morphine
Group 3	Pain control with single analgesics (ketorolac)	Intravenous administration of ketorolac

Primary Outcome Measures

Name	Time	Method
Amount of pain reduction by visual analog pain scale	At 30 and 60 minutes after primary study drug administration

Secondary Outcome Measures

Name	Time	Method
Additional analgesia requested by enrolled patients	At 30 and 60 minutes after primary study drug administration

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Kyeongi-do, Korea, Republic of