NCT00292214

Brief Summary

To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

March 9, 2007

Status Verified

February 1, 2006

First QC Date

February 13, 2006

Last Update Submit

March 8, 2007

Conditions

Laparoscopic Cholecystectomy

Keywords

paracetamolacetaminophenpharmacokineticintravenousoralanalgesiapainopioid

Outcome Measures

Primary Outcomes (1)

  • Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations

Secondary Outcomes (1)

  • Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.

Interventions

Paracetamol (acetaminophen)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18-75
  • Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia

You may not qualify if:

  • Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available.
  • History of allergy or sensitivity to paracetamol
  • Administration of oral paracetamol within previous 8 hours
  • American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity
  • Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Melbourne Hospital

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

AgnosiaPain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Malcolm Hogg, Anaesthetist

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 15, 2006

Study Start

October 1, 2005

Study Completion

October 1, 2006

Last Updated

March 9, 2007

Record last verified: 2006-02

Locations

AU(1)