Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01622881
First received: June 13, 2012
Last updated: August 18, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Kidney Transplantation
Drug: Normal saline
Drug: Nefopam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation : Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • Fentanyl consumption by patient-controlled analgesia [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Numerical rating score of pain [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Early postoperative graft function [ Time Frame: until discharge ] [ Designated as safety issue: Yes ]
    serum creatinine, estimated glomerular filtration rate, delayed graft function defined as the need for dialysis within 1 week after surgery, acute rejection episodes included both biopsy-proven and clinically suspected acute rejection


Enrollment: 98
Study Start Date: June 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nefopam Drug: Nefopam
Nefopam 160mg (16 mL) mixed to normal saline 184 mL : the infusion of 4mL/hr for post-operative 48 hours
Placebo Comparator: Control Drug: Normal saline
Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01622881

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Severance Hospital
  More Information

No publications provided

Responsible Party: So Yeon Kim, Clinical assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01622881     History of Changes
Other Study ID Numbers: 4-2012-0173
Study First Received: June 13, 2012
Last Updated: August 18, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Analgesics
Nefopam
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on August 26, 2014