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Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

NCT02361476 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2019-02-11

Study results available
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Summary

Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators don´t have data for characterization of the pharmacokinetic profile among age-groups for children 1-6 years.

In this study the investigators want to investigate if IV Clonidine administered at the end of surgery can prevent/reduce postoperative agitation. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.

Conditions

  • Psychomotor Agitation

Interventions

DRUG

Clonidine

Injection - during surgery

DRUG

Placebo

Injection - during surgery

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Steen Henneberg, MD, DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361476 on ClinicalTrials.gov