Completed

NCT Number: NCT02324413

Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Negative Behaviour Change

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bristol Dental Hospital

Bristol, BS2 8BJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

inability of parents to understand english

Treatment and study plan

Clonidine

Drug

Comparison between placebo and 2 different concentrations of clonidine

Placebo

Drug

Primary outcomes

Number of negative changes on the post-hospitalization behavior questionnaire

Time frame: 24 hours and 7 days

Sponsors and collaborators

Lead sponsor

Richard Beringer

Other

Registry information

Official study title

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?

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Dec 24, 2014
Registry last updated: Dec 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.