Comparing efficacy and safety between Naldebain^® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial.

ABSTRACT:

Background

A long-acting prodrug of nalbuphine, nalbuphine sebacate, has been developed for meeting the unmet medical need of long-acting analgesics. Naldebain^® (nalbuphine sebacate) has been developed as a new premedication for postoperative pain management. The primary objective of this study is to determine the efficacy and safety of a single dose of intramuscular Naldebain^® in patients scheduled to undergo elective laparotomy.

Methods/design

A total of 110 patients will be recruited and randomized into two treatment groups. Group 1 receives a single dose of Naldebain^® intramuscularly 24 ± 12 h prior to surgery. Group 2 receives intravenous patient-controlled analgesia (PCA) with fentanyl through 48 h postsurgery. Both groups will have fol

SUBMITTER: Tsai HL 

PROVIDER: S-EPMC6423831 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature