NCT00411307

A Randomized, Open-Label, Single-Dose, Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term, Moderate to Severe Postoperative Pain

A Randomized, Open-Label, Single-Dose, Pilot Study to Evaluate the Safety and Efficacy of OROS Hydromorphone in Patients With Acute, Moderate-to-Severe Postoperative Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Alza Corporation, DE, USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this small study was to investigate the safety and effectiveness of OROS hydromorphone HCI for the treatment of short-term, moderate to severe postoperative pain following total knee replacement surgery.

Detailed description

This was a multicenter, randomized (patients are assigned different treatments based on chance), open-label, single dose small study. During the 36 hour study period, concomitant analgesic (pain) medications and physical therapy were recorded in the patient's case report form. The study duration for each patient was 36 hours after a single dose of OROS hydromorphone HCI had been administered. After surgery, eligible patients had to tolerate liquids, swallow a tablet, and have audible bowel sounds. Before OROS hydromorphone HCI was administered, all analgesic medications were discontinued and patients with a pain score of 2(moderate pain) or 3 (severe pain) upon movement were eligible to enter the study and receive a single oral dose of OROS hydromorphone HCI. Patients had to have stable heart rates, blood pressure, respiration, oxygen saturation greater than or equal to 94% and patients who had undergone regional anesthesia had to have motor and sensory recovery from nerve blockade. Qualifying patients were given OROS hydromorphone HCI between 6 and 48 hours after completion of the surgical procedure. Patients were randomized into 3 groups (OROS hydromorphone HCI 8, 16, and 32 mg). The precise time of OROS hydromorphone HCI administration was considered time zero. To maintain consistency, dosing was to occur between 6 am and 2 pm, if possible. Following study drug administration, patients could be given rescue medication of oral hydromorphone immediate-release tablets (2 or 4 mg) for breakthrough pain as needed. Oxygen saturation, vital signs, pain relief ratings, and pain intensity ratings at rest and upon movement were obtained at 2-hour time intervals during the first 8 hours following study drug administration, and at 4 hour intervals from 8 to 36 hours following study drug administration. The study concluded 36 hours after dosing, at which time a global evaluation of pain relief was obtained from each patient. One single dose of OROS hydromorphone HCI (8, 16, or 32 mg) administered orally at the beginning of the 36 hour study.

Conditions

• Pain, Postoperative
• Orthopedic Procedures
• Analgesia

Interventions

Type	Name	Description
DRUG	OROS hydromorphone HCI

Timeline

• Completion: 2001-10-01
• First posted: 2006-12-14
• Last updated: 2010-04-27