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?
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 24, 2014
CompletedDecember 24, 2014
December 1, 2014
5 months
January 16, 2014
December 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of negative changes on the post-hospitalization behavior questionnaire
24 hours and 7 days
Study Arms (2)
clonidine
ACTIVE COMPARATORClonidine intravenous 1 or 2 micrograms / kg
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age 2 to 10 years inclusive
- healthy (ASA 1 or 2)
You may not qualify if:
- inability of parents to understand english
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Richard Beringerlead
Study Sites (1)
Bristol Dental Hospital
Bristol, BS2 8BJ, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
January 16, 2014
First Posted
December 24, 2014
Study Start
October 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
December 24, 2014
Record last verified: 2014-12