Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

Sponsor

Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01622881

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jun 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fentanyl consumption by patient-controlled analgesia [48 hours]
Numerical rating score of pain [48 hours]

Secondary Outcome Measures

The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia) [48 hours]
Early postoperative graft function [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

So Yeon Kim, Clinical assistant professor, Severance Hospital

ClinicalTrials.gov Identifier:

NCT01622881

Other Study ID Numbers:

4-2012-0173

First Posted:

Jun 19, 2012

Last Update Posted:

Aug 20, 2013

Last Verified:

Aug 1, 2013

Additional relevant MeSH terms:

Nefopam

Study Results

No Results Posted as of Aug 20, 2013