NCT01622881

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

1.1 years

First QC Date

June 13, 2012

Last Update Submit

August 18, 2013

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

  • Fentanyl consumption by patient-controlled analgesia

    48 hours

  • Numerical rating score of pain

    48 hours

Secondary Outcomes (2)

  • The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia)

    48 hours

  • Early postoperative graft function

    until discharge

Study Arms (2)

Nefopam

ACTIVE COMPARATOR
Drug: Nefopam

Control

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

Normal salineDRUG

Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours

Control
NefopamDRUG

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

Nefopam

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • elective living donor kidney transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

Saline SolutionNefopam

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsOxazocinesAzocinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 19, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

KR(1)