Interaction Between Nalbuphine and Morphine in PCA

This study is currently recruiting participants.

Verified by National Taiwan University Hospital, June 2005

First Received: September 8, 2005 Last Updated: November 22, 2005 History of Changes

Sponsor:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00155233

Purpose

Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
This study was designed to investigate the interaction between nalbuphine and morphine

Condition	Intervention	Phase
Postoperative Pain	Drug: Nalbuphine and morphine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Interaction Between Nalbuphine and Morphine in Postoperative PCA for Gynecologic Patients

Resource links provided by NLM:

Drug Information available for: Nalbuphine Nalbuphine hydrochloride

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

analgesic effect

Secondary Outcome Measures:

incidence of opioid-related side effects

Estimated Enrollment:	200
Study Start Date:	January 2005

Detailed Description:

Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
This study was designed to investigate the interaction between nalbuphine and morphine
The analgesic effect and opioid-related side effects will be investigated

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-65 y/o
Female patients of ASA physical status I to III
Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian tumor

Exclusion Criteria:

Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants)
Intraoperative fentanyl use > 3 μg/kg
Patients with definite diagnosis of esophageal reflux syndrome
Use of sedatives, antiemetics, or antipruritics within 24 hours before operation
Surgery > 4 hours or laparoscopy surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00155233

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Yu Chang Yeh, MD cooltony@ha.mc.ntu.edu.tw
Principal Investigator: Wei-Zen Sun, MD

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Wei-Zen Sun, MD

National Taiwan University Hospital

More Information

No publications provided

Study ID Numbers:	931002
Study First Received:	September 8, 2005
Last Updated:	November 22, 2005
ClinicalTrials.gov Identifier:	NCT00155233 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

analgeisa
postoperatve
side effects

Additional relevant MeSH terms:

Morphine
Nalbuphine
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms

Pathologic Processes
Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010