Pilot Study: Intraoperative Clonidine and Postoperative B... | NCT02324413

Studies
Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

NCT02324413

Sponsor

Richard Beringer

Status

Completed

Last Update Posted

Dec 24, 2014Estimated

Enrollment

45Actual

Phase

Phase 3

Conditions

Negative Behaviour Change

Interventions

Clonidine
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jan 16, 2014

First Submission Date that Met QC Criteria

Dec 23, 2014

First Posted Date

Dec 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2014

Last Update Posted Date

Dec 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Richard Beringer, Dr, University Hospitals Bristol and Weston NHS Foundation TrustSponsor-Investigator

Lead Sponsor

Richard BeringerOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clonidine	Active Comparator	Clonidine intravenous 1 or 2 micrograms / kg	Drug: Clonidine
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clonidine	Drug	Comparison between placebo and 2 different concentrations of clonidine	clonidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of negative changes on the post-hospitalization behavior questionnaire		24 hours and 7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

inability of parents to understand english

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bristol Dental Hospital		Bristol		BS2 8BJ	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D003000	Clonidine

Ancestor Terms

ID	Term
D048288	Imidazolines
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided