Analgesia Disorder Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-controlled, Multiple Dose Study to Assess the Efficacy, Safety and Pharmacokinetics of Oral Nalbuphine, an Oral Soft Capsule, for Post-hemorrhoidectomy Pain Management
The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
• Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours. • Secondary Efficacy Endpoints: 1. Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection). 2. Time from the end of operation to the first IM injection diclofenac dose 3. Brief Pain Inventory (BPI). 4. Patient satisfaction. ;
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