A Double-blinded Randomised Evaluation of Alfentanil and Morphine versus Fentanyl: Analgesia and Sleep Trial.

Phase 3

Completed

• Conditions: Post-operative Analgesia; Post-operative Sleep; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12608000118303
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients scheduled to undergo inpatient surgery where Patient-Controlled Intravenous Analgesia is indicated post-operatively, who are capable of providing informed consent, understanding how to use the PCIA device and activating the PCIA device.

Exclusion Criteria

American Society of Anesthesiologists (ASA) Physical status 4 or 5, renal or hepatic failure, obstructive sleep apnoea requiring treatment, allergy to morphine, alfentanil or fentanyl, history of opioid abuse or chronic opioid use, inability to use the PCIA device, inability to complete the questionnaire, use of a continuous regional analgesic technique, previous participation in this trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of pain related awakenings on the second post-operative night, as self-reported by patients the following morning on the trial questionnaire (modified St Mary's Hospital Sleep Questionnaire)[Second post-operative morning]

Secondary Outcome Measures

Name	Time	Method
Sleep quality as subjectively rated by patients via Likert Scale on the trial questionnaire (modified St Mary's Hospital Sleep Questionnaire)[Second post-operative morning]