Interaction Between Nalbuphine and Morphine in PCA
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Nalbuphine and morphine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Wei-Zen Sun, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Summary
1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
2. This study was designed to investigate the interaction between nalbuphine and morphine
Clinical Details
Official title: Interaction Between Nalbuphine and Morphine in Postoperative PCA for Gynecologic Patients
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: analgesic effect
Secondary outcome: incidence of opioid-related side effects
Detailed description:
1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
2. This study was designed to investigate the interaction between nalbuphine and morphine
3. The analgesic effect and opioid-related side effects will be investigated
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Age 18-65 y/o
2. Female patients of ASA physical status I to III
3. Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian
tumor
Exclusion Criteria:
1. Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders,
or drug abuse (include opioids, NSAIDs, sedatives, antidepressants)
2. Intraoperative fentanyl use > 3 μg/kg
3. Patients with definite diagnosis of esophageal reflux syndrome
4. Use of sedatives, antiemetics, or antipruritics within 24 hours before operation
5. Surgery > 4 hours or laparoscopy surgery
Locations and Contacts
National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting
Yu Chang Yeh, MD, Email: cooltony@ha.mc.ntu.edu.tw
Wei-Zen Sun, MD, Principal Investigator
Additional Information
Starting date: January 2005
Last updated: November 22, 2005
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