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