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Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

Information source: University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Negative Behaviour Change

Intervention: Clonidine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Richard Beringer


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.

Clinical Details

Official 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?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Number of negative changes on the post-hospitalization behavior questionnaire


Minimum age: 2 Years. Maximum age: 10 Years. Gender(s): Both.


Inclusion Criteria:

- age 2 to 10 years inclusive

- healthy (ASA 1 or 2)

Exclusion Criteria:

- inability of parents to understand english

Locations and Contacts

Bristol Dental Hospital, Bristol BS2 8BJ, United Kingdom
Additional Information

Starting date: October 2013
Last updated: December 23, 2014

Page last updated: August 20, 2015

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