Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

September 11, 2018 updated by: Mogens Ydemann, Rigshospitalet, Denmark

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Clonidine is widely used off-label in children for several indications such as treatment and/or prevention of postoperative agitation when anaesthetised with Sevoflurane. However, the current level of evidence in support of Clonidine treatment for postoperative agitation in children remains limited. In addition, the pharmacokinetic profile of intravenous Clonidine in children is not well characterized for age-groups.

METHODS/DESIGN:

In this prospective multicentre double-blinded randomized clinical trial, the investigators aim to investigate the impact of intravenous (IV) Clonidine administered at the end of surgery, on the incidence and degree of postoperative agitation. Children will be assigned to either the intervention or the placebo group. The allocation will be carried out centrally and stratified based on age and trial-site, with152 patients allocated to each group. In the intervention group, 3 micrograms per kg of IV clonidine is administered approximately 20 minutes before the expected completion of the surgery (as assessed by the surgeon). In the control group; Saline (placebo) is injected in equal quantity during surgery at the same time. The drugs are concealed in identical blinded ampoules.

The primary outcome is postoperative agitation measured on the Watcha scale. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including 30-day follow-up.

Twenty of the patients age 1-2 years and twenty age >2 years, with a peripheral venous access in place, will be allocated to drug assay sampling; enabling a compartmental PK analysis based on age group, using non-linear mixed effects models.

Study Type

Interventional

Enrollment (Actual)

379

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Køge Sygehus, Anæstesiologisk Afdeling
      • Vejle, Denmark, 7100
        • Anæstesiologisk afdeling, Vejle Sygehus
    • Zealand
      • Copenhagen, Zealand, Denmark, 2100
        • The Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled for surgery with Sevoflurane as the choice of anesthesia.

Exclusion Criteria:

  • ASA classification >2
  • Premedication with Clonidine
  • Ex-premature (born before week 37+0 AND <60 weeks old)
  • Intubated before anaesthesia and/or no plans for extubation after anaesthesia.
  • Critical illness with haemodynamic instability.
  • Active bleeding.
  • Cancer.
  • Cardiac diseases including arrhythmias.
  • Malignant hyperthermia.
  • Mental retardation.
  • Neurological illness with agitation-like symptoms.
  • Weight >50 kg.
  • Allergy to Clonidine.
  • Patients treated with methylphenidate / Concerta.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Clonidine : injection og 3 micg/kg IV during the operation.
Drug: Clonidine
Injection - during surgery
Other Names:
  • catapresan
Placebo Comparator: Placebo
Placebo : injection og equal amount of NaCl IV during the operation.
Drug: Placebo
Injection - during surgery
Other Names:
  • NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Agitation
Time Frame: 1 day
Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fentanyl and Morphine Requirements
Time Frame: Recorded during the stay in the postoperative recovery room
Amount used
Recorded during the stay in the postoperative recovery room
Pain Assessment
Time Frame: recovery room - hours

Pain score used:

FLACC score = Face, Legs, Activity, Cry, Consolability Score ranges from 0 to 10 (severity increases with increasing score) Pain is FLACC score more than 3
recovery room - hours
First Administration of Fentanyl or Morphine
Time Frame: recovery room
Time to administration
recovery room
Adverse Events
Time Frame: from intervention to discharge from the recovery room
from intervention to discharge from the recovery room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Steen Henneberg, MD, DMSc, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 1, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H - 2 - 2014 - 072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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