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CompletedNCT02324413Updated Dec 24, 2014

Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

A Phase 3 interventional study of Clonidine and Placebo in Negative Behaviour Change, sponsored by Richard Beringer. Completed at 1 site in United Kingdom. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2014-12-24.

Sponsored by Richard Beringer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
2 Years to 10 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Negative Behaviour Change
03

In context

Lead sponsor

This is the only study on the registry with Richard Beringer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • inability of parents to understand english
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    clonidine

    Clonidine intravenous 1 or 2 micrograms / kg

    Drug: Clonidine

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugClonidine

    Comparison between placebo and 2 different concentrations of clonidine

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Number of negative changes on the post-hospitalization behavior questionnaire

    Time frame: 24 hours and 7 days

07

Study locations

1 site
  • Bristol Dental Hospital
    Bristol, BS2 8BJ, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02324413
Lead sponsor
Richard Beringer
Responsible party
Richard Beringer (Dr, University Hospitals Bristol and Weston NHS Foundation Trust) — Sponsor-investigator
First posted
Dec 24, 2014
Start date
Oct 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Dec 24, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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