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

A Single Center, Prospective Randomized Double-blind Trial: Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

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.

Study Overview

• Status: Unknown
• Conditions: Renal Colic
• Intervention / Treatment: Drug: Ketorolac and nefopam balanced analgesia; Drug: Balanced analgesia using ketorolac and morphine; Drug: Pain control with single analgesics (ketorolac)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 111
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kyuseok Kim, MD; Phone Number: 82-31-787-3049; Email: dremkks@snubh.org
• Study Contact Backup: Name: Joonghee Kim, MD; Phone Number: 82-10-9489-3696; Email: joonghee@me.com

Study Locations

• Korea, Republic of
  • Kyeongi-do
    • Seongnam-si, Kyeongi-do, Korea, Republic of
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Kyuseok Kim, MD; Phone Number: 82-31-787-3049; Email: dremkks@snubh.org
      • Contact: Joonghee Kim, MD; Phone Number: 82-10-9489-3696; Email: joonghee@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Sequential intravenous administration of ketorolac and nefopam	Drug: Ketorolac and nefopam balanced analgesia; Sequential intravenous administration of ketorolac and nefopam
Active Comparator: Group 2; Sequential intravenous administration of ketorolac and morphine	Drug: Balanced analgesia using ketorolac and morphine; Sequential intravenous administration of ketorolac and morphine
Placebo Comparator: Group 3; Intravenous administration of ketorolac	Drug: Pain control with single analgesics (ketorolac); This arm do not use balanced analgesia. Instead, ketorolac IV administration followed by 50cc normal saline administration (for blinding) will be used in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of pain reduction by visual analog pain scale	At 30 and 60 minutes after primary study drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Additional analgesia requested by enrolled patients	At 30 and 60 minutes after primary study drug administration

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Pharmbio Korea

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Analgesia; Ketorolac; Renal colic; Nefopam
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Renal Colic; Colic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Ketorolac; Morphine; Analgesics; Ketorolac Tromethamine; Nefopam
• Other Study ID Numbers: B-1112/141-011