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Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

NCT ID: NCT01622881

Last Updated: 2013-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-07-31

Brief Summary

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The investigators examined the efficacy of nefopam in patients undergoing kidney transplantation.

Detailed Description

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Drug combination are frequently used to relieve postoperative pain. Nefopam can inhibit serotonin, dopamine, and norepinephrine reuptake through central mechanisms. Several studies have demonstrated analgesic efficacy of nefopam in the postoperative period. The purpose of this study is to ascertain the analgesic effect and tolerance of intravenous nefopam in combination with fentanyl based patient-controlled analgesia after kidney transplantation.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nefopam

Group Type ACTIVE_COMPARATOR

Nefopam

Intervention Type DRUG

Nefopam 160mg (16 mL) mixed to normal saline 184 mL : the infusion of 4mL/hr for post-operative 48 hours

Control

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours

Interventions

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Normal saline

Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours

Intervention Type DRUG

Nefopam

Nefopam 160mg (16 mL) mixed to normal saline 184 mL : the infusion of 4mL/hr for post-operative 48 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* elective living donor kidney transplantation

Exclusion Criteria

* pre-operative tachycardia (\> 100bpm)
* liver dysfunction
* severe cardiac disease
* body mass index ≥ 30 kg/m2
* drug allergy
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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So Yeon Kim

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2012-0173

Identifier Type: -

Identifier Source: org_study_id