Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622881
• Other study ID #: 4-2012-0173
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: August 18, 2013
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Normal saline
Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours
• Nefopam
Nefopam 160mg (16 mL) mixed to normal saline 184 mL : the infusion of 4mL/hr for post-operative 48 hours

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fentanyl consumption by patient-controlled analgesia		48 hours	Yes
Primary	Numerical rating score of pain		48 hours	No
Secondary	The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia)		48 hours	Yes
Secondary	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	Yes