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Trial record 13 of 1936 for:    Open Studies | "Analgesics"
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Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

This study is currently recruiting participants.
Verified December 2012 by Seoul National University Hospital
Sponsor:
Collaborator:
Pharmbio Korea
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01543165
First received: February 27, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Renal Colic
 Drug: Ketorolac and nefopam balanced analgesia
Drug: Balanced analgesia using ketorolac and morphine
Drug: Pain control with single analgesics (ketorolac)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Single Center, Prospective Randomized Double-blind Trial: Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Amount of pain reduction by visual analog pain scale [ Time Frame: At 30 and 60 minutes after primary study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional analgesia requested by enrolled patients [ Time Frame: At 30 and 60 minutes after primary study drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 111
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543165

Contacts
Contact: Kyuseok Kim, MD 82-31-787-3049 dremkks@snubh.org
Contact: Joonghee Kim, MD 82-10-9489-3696 joonghee@me.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Kyeongi-do, Korea, Republic of
Contact: Kyuseok Kim, MD     82-31-787-3049     dremkks@snubh.org    
Contact: Joonghee Kim, MD     82-10-9489-3696     joonghee@me.com    
Sponsors and Collaborators
Seoul National University Hospital
Pharmbio Korea
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01543165     History of Changes
Other Study ID Numbers: B-1112/141-011
Study First Received: February 27, 2012
Last Updated: December 13, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Renal colic
Analgesia
Nefopam
Ketorolac

Additional relevant MeSH terms:
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Renal Colic
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Nefopam
Morphine
Ketorolac
Ketorolac Tromethamine
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013