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

Renal Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01543165
• Other study ID #: B-1112/141-011
• Status: Recruiting
• Phase: Phase 4
• First received: February 27, 2012
• Last updated: December 13, 2012
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Seoul National University Hospital
• Contact: Kyuseok Kim, MD
• Phone: 82-31-787-3049
• Email: dremkks[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Drug:
• Ketorolac and nefopam balanced analgesia
Sequential intravenous administration of ketorolac and nefopam
• Balanced analgesia using ketorolac and morphine
Sequential intravenous administration of ketorolac and morphine
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Kyeongi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Pharmbio Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of pain reduction by visual analog pain scale		At 30 and 60 minutes after primary study drug administration	No
Secondary	Additional analgesia requested by enrolled patients		At 30 and 60 minutes after primary study drug administration	No