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Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

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?

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02324413
Enrollment
45
Registered
2014-12-24
Start date
2013-10-31
Completion date
2014-03-31
Last updated
2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Negative Behaviour Change

Brief 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.

Interventions

DRUGClonidine

Comparison between placebo and 2 different concentrations of clonidine

DRUGPlacebo

Sponsors

Richard Beringer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* inability of parents to understand english

Design outcomes

Primary

MeasureTime frame
Number of negative changes on the post-hospitalization behavior questionnaire24 hours and 7 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026