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

Primary Purpose

Renal Colic

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ketorolac and nefopam balanced analgesia

Balanced analgesia using ketorolac and morphine

Pain control with single analgesics (ketorolac)

About this trial

This is an interventional treatment trial for Renal Colic focused on measuring Renal colic, Analgesia, Nefopam, Ketorolac

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Sequential intravenous administration of ketorolac and nefopam

Sequential intravenous administration of ketorolac and morphine

Intravenous administration of ketorolac

Outcomes

Primary Outcome Measures

Amount of pain reduction by visual analog pain scale

Secondary Outcome Measures

Additional analgesia requested by enrolled patients

Full Information

NCT ID

NCT01543165

First Posted

February 27, 2012

Last Updated

December 13, 2012

Sponsor

Seoul National University Hospital

Collaborators

Pharmbio Korea

1. Study Identification

Unique Protocol Identification Number

NCT01543165

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

Collaborators

Pharmbio Korea

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Colic

Keywords

Renal colic, Analgesia, Nefopam, Ketorolac

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

111 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Sequential intravenous administration of ketorolac and nefopam

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Sequential intravenous administration of ketorolac and morphine

Arm Title

Group 3

Arm Type

Placebo Comparator

Arm Description

Intravenous administration of ketorolac

Intervention Type

Drug

Intervention Name(s)

Ketorolac and nefopam balanced analgesia

Intervention Description

Sequential intravenous administration of ketorolac and nefopam

Intervention Type

Drug

Intervention Name(s)

Balanced analgesia using ketorolac and morphine

Intervention Description

Sequential intravenous administration of ketorolac and morphine

Intervention Type

Drug

Intervention Name(s)

Pain control with single analgesics (ketorolac)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Amount of pain reduction by visual analog pain scale

Time Frame

At 30 and 60 minutes after primary study drug administration

Secondary Outcome Measure Information:

Title

Additional analgesia requested by enrolled patients

Time Frame

At 30 and 60 minutes after primary study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kyuseok Kim, MD

Phone

82-31-787-3049

dremkks@snubh.org

First Name & Middle Initial & Last Name or Official Title & Degree

Joonghee Kim, MD

Phone

82-10-9489-3696

joonghee@me.com

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Kyeongi-do

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kyuseok Kim, MD

Phone

82-31-787-3049

dremkks@snubh.org

First Name & Middle Initial & Last Name & Degree

Joonghee Kim, MD

Phone

82-10-9489-3696

joonghee@me.com

12. IPD Sharing Statement

Learn more about this trial

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

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