Analgesic Efficacy of Nefopam in Patients Undergoing Kidn... | NCT01622881

Studies
Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

NCT01622881

Sponsor

Severance Hospital

Status

Completed

Last Update Posted

Aug 20, 2013Estimated

Enrollment

98Actual

Phase

Not Applicable

Conditions

Kidney Transplantation

Interventions

Normal saline
Nefopam

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jun 13, 2012

First Submission Date that Met QC Criteria

Jun 18, 2012

First Posted Date

Jun 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2013

Last Update Posted Date

Aug 20, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nefopam	Active Comparator		Drug: Nefopam
Control	Placebo Comparator		Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Normal saline	Drug	Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours	Control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution
D009340	Nefopam

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided