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Trial record 36 of 328 for:    clonidine

Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 16, 2014
First Posted Date  ICMJE December 24, 2014
Last Update Posted Date December 24, 2014
Study Start Date  ICMJE October 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
Number of negative changes on the post-hospitalization behavior questionnaire [ Time Frame: 24 hours and 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study: Intraoperative Clonidine and Postoperative Behaviour
Official Title  ICMJE 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?
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Negative Behaviour Change
Intervention  ICMJE
  • Drug: Clonidine
    Comparison between placebo and 2 different concentrations of clonidine
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: clonidine
    Clonidine intravenous 1 or 2 micrograms / kg
    Intervention: Drug: Clonidine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2014)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • inability of parents to understand english
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02324413
Other Study ID Numbers  ICMJE CH-2011-3668
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Beringer, University Hospitals Bristol NHS Foundation Trust
Study Sponsor  ICMJE Richard Beringer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospitals Bristol NHS Foundation Trust
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP