Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

December 23, 2014 updated by: Richard Beringer

Randomised Controlled Pilot Study: Does Intraoperative Clonidine Reduce the Incidence of Post-hospitalisation Negative Behaviour Changes in Children Who Are Distressed During the Induction of General Anaesthesia?

Children who are upset during induction of general anaesthesia are frequently distressed postoperatively and are more likely to demonstrate negative behaviour changes.

This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia to identify whether postoperative behavioural disturbance may be minimised.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Bristol Dental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 2 to 10 years inclusive
  • healthy (ASA 1 or 2)

Exclusion Criteria:

  • inability of parents to understand english

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: clonidine
Clonidine intravenous 1 or 2 micrograms / kg
Drug: Clonidine
Comparison between placebo and 2 different concentrations of clonidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of negative changes on the post-hospitalization behavior questionnaire
Time Frame: 24 hours and 7 days
24 hours and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Richard Beringer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-2011-3668

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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