Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation : Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Nefopam; Drug: Normal saline

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
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control	Drug: Normal saline; Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fentanyl consumption by patient-controlled analgesia	48 hours
Numerical rating score of pain	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia)		48 hours
Early postoperative graft function	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	until discharge

Collaborators and Investigators

• Sponsor: Severance Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (ESTIMATE): June 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 18, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Nefopam
• Other Study ID Numbers: 4-2012-0173