Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

Not Applicable

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Nefopam; Drug: Normal saline

• Registration Number: NCT01622881
• Lead Sponsor: Severance Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-18
• Last Update Posted: 2013-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• elective living donor kidney transplantation

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nefopam	Nefopam	-
Control	Normal saline	-

Primary Outcome Measures

Name	Time	Method
Fentanyl consumption by patient-controlled analgesia	48 hours
Numerical rating score of pain	48 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of