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NCT02324413 Clinical Trial

Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

Negative Behaviour Change Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02324413
Other study ID # CH-2011-3668
Secondary ID
Status Completed
Phase Phase 3
First received January 16, 2014
Last updated December 23, 2014
Start date October 2013
Est. completion date March 2014

Study information
Verified date December 2014
Source University Hospitals Bristol NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 10 Years
Eligibility Inclusion Criteria:

- age 2 to 10 years inclusive

- healthy (ASA 1 or 2)

Exclusion Criteria:

- inability of parents to understand english

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Clonidine
Comparison between placebo and 2 different concentrations of clonidine
• Placebo

Locations
Country Name City State
United Kingdom Bristol Dental Hospital Bristol

Sponsors (1)
Lead Sponsor Collaborator
Richard Beringer

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of negative changes on the post-hospitalization behavior questionnaire 24 hours and 7 days No