Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01622881
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : August 20, 2013
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital

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

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Normal saline Drug: Nefopam Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation : Randomized Controlled Study
Study Start Date : June 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Fentanyl consumption by patient-controlled analgesia [ Time Frame: 48 hours ]
  2. Numerical rating score of pain [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia) [ Time Frame: 48 hours ]
  2. Early postoperative graft function [ Time Frame: until discharge ]
    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

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01622881

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

Responsible Party: So Yeon Kim, Clinical assistant professor, Severance Hospital Identifier: NCT01622881     History of Changes
Other Study ID Numbers: 4-2012-0173
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic