Kidney Transplantation
Conditions
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.
Interventions
DRUGNormal saline
Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours
DRUGNefopam
Nefopam 160mg (16 mL) mixed to normal saline 184 mL : the infusion of 4mL/hr for post-operative 48 hours
Sponsors
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fentanyl consumption by patient-controlled analgesia | 48 hours |
| Numerical rating score of pain | 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia) | 48 hours | — |
| Early postoperative graft function | 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 |
Countries
South Korea
Outcome results
None listed