CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 379 enrolled
Drug / intervention
Clonidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02361476
NCT02361476Phase 4Completed
CompareCT.gov

Does Intraoperative Clonidine Reduce Post Operative Agitation in Children Anaesthetised With Sevoflurane? A RCT Including Pharmacokinetic Investigation.

Rigshospitalet, Denmark·interventional·Posted Feb 11, 2015·Updated Feb 11, 2019

In Brief

A Phase 4 clinical trial evaluating Clonidine and Placebo for Psychomotor Agitation. Completed, enrolled 379 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsychomotor Agitation
CountriesDenmark
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 11, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.4 years ago

Interventions

Clonidinedrug

Injection - during surgery

Placebodrug

Injection - during surgery