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Interaction Between Nalbuphine and Morphine in PCA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00155233
Recruitment Status : Unknown
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : November 23, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Nalbuphine and morphine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Interaction Between Nalbuphine and Morphine in Postoperative PCA for Gynecologic Patients
Study Start Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions




Primary Outcome Measures :
  1. analgesic effect

Secondary Outcome Measures :
  1. incidence of opioid-related side effects


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155233


Locations
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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
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Principal Investigator: Wei-Zen Sun, MD National Taiwan University Hospital
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ClinicalTrials.gov Identifier: NCT00155233    
Other Study ID Numbers: 931002
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 23, 2005
Last Verified: June 2005
Keywords provided by National Taiwan University Hospital:
analgeisa
postoperatve
side effects
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents