The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy Surgery

Summary

The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be performed by administering NALDEBAIN pre-operatively to subjects scheduled to undergo elective laparotomy, and assessing the safety and efficacy of the drug compared to PCA with fentanyl. The study will demonstrate whether single use of NALDEBAIN is noninferior to PCA with fentanyl or not.

Timeline

Start

2017-08-17

Primary completion

2018-12-31

Completion

2018-12-31

Publications

• Chang TK, Huang CW, Su WC, Tsai HL, Ma CJ, Yeh YS, Chen YC, Li CC, Cheng KI, Su MP, Wang JY. Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial. Pain Ther. 2020 Dec;9(2):671-681. doi: 10.1007/s40122-020-00197-x. Epub 2020 Sep 29.
• Tsai HL, Chang TK, Su WC, Yeh YS, Huang CW, Ma CJ, Wang JY. Comparing efficacy and safety between Naldebain(R) and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial. Trials. 2019 Mar 18;20(1):173. doi: 10.1186/s13063-019-3260-4.

Drugs

Indications