drugset / Trial / NCT02747628

Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

NCT02747628

Phase 4 Completed 60 enrolled Ain Shams University
RandomizedParallel-groupTriple-blindOther

Summary

Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective laparoscopic cholecystectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.

Timeline

Start
2013-04
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 7 mg Other
Comparator Nicotine Unknown 15 mg Other

Indications

No indication recorded.