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Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

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ClinicalTrials.gov Identifier: NCT02324413
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Richard Beringer, University Hospitals Bristol NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Negative Behaviour Change Drug: Clonidine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: clonidine
Clonidine intravenous 1 or 2 micrograms / kg
Drug: Clonidine
Comparison between placebo and 2 different concentrations of clonidine

Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of negative changes on the post-hospitalization behavior questionnaire [ Time Frame: 24 hours and 7 days ]


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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • inability of parents to understand english

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324413


Locations
United Kingdom
Bristol Dental Hospital
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
Richard Beringer

Responsible Party: Richard Beringer, Dr, University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02324413     History of Changes
Other Study ID Numbers: CH-2011-3668
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action