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Completed

NCT Number: NCT01622881

Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

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

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Key information

Conditions

Kidney Transplantation

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

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

Nefopam

Drug

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

Primary outcomes

  1. Fentanyl consumption by patient-controlled analgesia

    Time frame: 48 hours

  2. Numerical rating score of pain

    Time frame: 48 hours

Secondary outcomes

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

    Time frame: 48 hours

  2. Early postoperative graft function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2012
Registry last updated
Aug 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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