Completed

A Single Centre Prospective Randomised Study to Investigate the Cerebrospinal Fluid (CSF) Pharmacokinetics of Intravenous Paracetamol in Humans

What is being tested

Administration of paracetamol

+ Administration of paracetamol

Drug

Who is being recruted

From 18 to 80 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Phase 4

Interventional

Study Start: May 2011

See protocol details

Summary

Principal SponsorBarts & The London NHS Trust

Last updated: April 4, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

Patients undergoing spinal blockade for urological surgery were administered 1g paracetamol intravenously at varying intervals prior to spinal anaesthesia, at which time 5mls of cerebrospinal fluid and 10mls of blood were sampled, and analysed for concentrations of paracetamol, paracetamol glucuronide, paracetamol sulphate, and AM404, a known endocannabinoid reuptake inhibitor, and metabolite of paracetamol. Paracetamol readily penetrates into the cerebrospinal fluid in animal studies and in children. This could account for the rapid central analgesic and antipyretic action of intravenous paracetamol however this remains to be studied in adults. AM404 has never before been identified in humans, and its presence in CSF following paracetamol supports the hypothesis of a central mechanism of action of paracetamol via AM404.

NCT01821872

Principal SponsorBarts & The London NHS Trust

Last updated: April 4, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

Adult subjects aged 18 to 80 years

Subjects undergoing surgery who require a spinal anaesthetic and paracetamol as part of their routine anaesthetic plan

Subjects with an American Society of Anesthesiology score of I-III

7 exclusion criteria prevent from participating

Any subjects deemed medically unsuitable by the investigator

Patients already taking regular doses of paracetamol

Patients with severe hepatocellular insufficiency

Pregnant or lactating women

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Plasma and CSF samples to be taken at 15 minutes post administration of intravenous paracetamol

Group II

Active Comparator

Plasma and CSF samples to be taken at 30 minutes post administration of intravenous paracetamol

Group III

Active Comparator

Plasma and CSF samples to be taken at 120 minutes post administration of intravenous paracetamol

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

St Bartholomew's Hospital

London, United KingdomOpen St Bartholomew's Hospital in Google Maps

CompletedOne Study Center