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Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

NCT ID: NCT02324413

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Negative Behaviour Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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clonidine

Clonidine intravenous 1 or 2 micrograms / kg

Group Type ACTIVE_COMPARATOR

Clonidine

Intervention Type DRUG

Comparison between placebo and 2 different concentrations of clonidine

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Clonidine

Comparison between placebo and 2 different concentrations of clonidine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* inability of parents to understand english
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Richard Beringer

OTHER

Sponsor Role lead

Responsible Party

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Richard Beringer

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Bristol Dental Hospital

Bristol, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CH-2011-3668

Identifier Type: -

Identifier Source: org_study_id