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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00155233
Other study ID # 931002
Secondary ID
Status Recruiting
Phase Phase 4
First received September 8, 2005
Last updated November 22, 2005
Start date January 2005

Study information

Verified date June 2005
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nalbuphine and morphine


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary analgesic effect
Secondary incidence of opioid-related side effects
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