Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

Richard Beringer

Status and phase: Completed; Phase 3

Conditions: Negative Behaviour Change

Treatments: Drug: Placebo; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02324413

CH-2011-3668

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• inability of parents to understand english

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

clonidine

Active Comparator group

Description:

Clonidine intravenous 1 or 2 micrograms / kg

Treatment:

Drug: Clonidine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo