Morphine vs. Oxycodone for Postoperative Pain Management
Phase 4: A Comparison of Intravenous Administration of Morphine vs. Oxycodone for Postoperative Pain Management Following Laparoscopic Hysterectomy or Myomectomy
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to determine whether oxycodone provides better analgesia compared to morphine after laparoscopic hysterectomy or myomectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 11, 2007
CompletedFirst Posted
Study publicly available on registry
September 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJuly 6, 2011
June 1, 2007
9 months
September 11, 2007
July 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dosage relation between oxycodone and morphine. Pain score (VAS). Adverse effects.
Within the first postoperative day (24 hours).
Study Arms (2)
O
ACTIVE COMPARATORThis arm will receive intravenous oxycodone at the end of surgery and PCA oxycodone for postoperative pain relief.
M
ACTIVE COMPARATORThis arm will receive intravenous morphine at the end of surgery and PCA morphine for postoperative pain relief.
Interventions
At the end of surgery, group 1 will receive intravenous morphine 0.07 mg/kg and intravenous PCA morphine 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours. Group 2 will receive intravenous oxycodone 0.07 mg/kg and intravenous PCA oxycodone 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours. The patients will use the PCA until the next morning.
Eligibility Criteria
You may qualify if:
- Patients (American Society of Anaesthesiologists (ASA) I, II and III) due for elective, laparoscopic, non-malignant gynaecologic surgery: Hysterectomy or myomectomy.
- Written informed consent.
- Age: 18 to 70 years.
You may not qualify if:
- Patients having used non-steroidal anti-inflammatory drugs (NSAIDs) the last 24 hours.
- Sensitivity towards the study drugs.
- Cardiovascular risk conditions: Heart failure, unstable hypertension, coronary artery disease.
- Patients using opioids, steroids or anti-emetic drugs.
- Serious mental disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ullevaal University Hospitallead
- University of Oslocollaborator
Study Sites (1)
Ullevaal University Hospital
Oslo, Oslo County, 0407, Norway
Related Publications (1)
Lenz H, Sandvik L, Qvigstad E, Bjerkelund CE, Raeder J. A comparison of intravenous oxycodone and intravenous morphine in patient-controlled postoperative analgesia after laparoscopic hysterectomy. Anesth Analg. 2009 Oct;109(4):1279-83. doi: 10.1213/ane.0b013e3181b0f0bb.
PMID: 19762758DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johan Ræder, Prof.MD,Phd
Ullevaal University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 11, 2007
First Posted
September 12, 2007
Study Start
September 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 6, 2011
Record last verified: 2007-06