The Hydromorphone Trial

Phase 4

Recruiting

• Conditions: Analgesia for Postoperative Pain; Alternative and Complementary Medicine - Pain management

• Registration Number: ACTRN12605000292673
• Lead Sponsor: Stephen Lim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

ASA 1 or 2. Major Gynaecological Surgery involving skin or mucosal incision (e.g. laparotomy, total abdominal hysterectomy, vaginal hysterectomy +/- anterior/posterior repair).Decision to use patient controlled intravenous analgesia (PCIA) in the postoperative period.

Exclusion Criteria

Nasal pathology.Allergy to shellfish (chitosan a natural constituent of mollusc seashell is added to the hydromorphone mixture to aid in prolonging mucosal absorption).Intolerance to opioids.Decision to use epidural analgesia postoperatively.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical effectiveness of a single dose of 2mg hydromorphone administered intranasally, as measured by redution of pain intensity at rest, compared with the administration of 1mg hydromorphone intravenously.[Pain scores (visual analogue scale - VAS) will be collected immediately prior to (baseline) and at 5, 15, 30, 60, 120 and 180 minutes after each method of hydromorphone administration.]

Secondary Outcome Measures

Name	Time	Method
ausea, sedation and pruritus scores (VAS).[Collected immediately prior to and 60 minutes after hydromorphone administration.];Presence of side effects including pain or burning in the nasal passages.[After intransal administration.];Patient preference/acceptability - intranasal versus intravenous.[];Change in oxygen saturation post dose measured by pulse oximetry.[];Drug Kinetics (bioavailability, volume of distribution, elimination) of intranasal hydromorphone.[Blood sampled via IV cannula at 2, 5, 15, 30, 60, 120, 180 minutes after administration for both routes.]