NCT00155233

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

November 23, 2005

Status Verified

June 1, 2005

First QC Date

September 8, 2005

Last Update Submit

November 22, 2005

Conditions

Postoperative Pain

Keywords

analgeisapostoperatveside effects

Outcome Measures

Primary Outcomes (1)

  • analgesic effect

Secondary Outcomes (1)

  • incidence of opioid-related side effects

Interventions

Nalbuphine and morphineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

NalbuphineMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsMorphine Derivatives

Study Officials

  • Wei-Zen Sun, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2005

Last Updated

November 23, 2005

Record last verified: 2005-06

Locations

TW(1)