Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

Phase 4

Completed

Conditions: Psychomotor Agitation

Interventions: Drug: Placebo
Drug: Clonidine

Registration Number: NCT02361476

Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 379

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo : injection og equal amount of NaCl IV during the operation.
Intervention	Clonidine	Clonidine : injection og 3 micg/kg IV during the operation.

Primary Outcome Measures

Name	Time	Method
Postoperative Agitation	1 day	Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated

Secondary Outcome Measures

Name	Time	Method
First Administration of Fentanyl or Morphine	recovery room	Time to administration
Fentanyl and Morphine Requirements	Recorded during the stay in the postoperative recovery room	Amount used
Pain Assessment	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
Adverse Events	from intervention to discharge from the recovery room

Trial Locations

Locations (3): Køge Sygehus, Anæstesiologisk Afdeling
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Køge, Denmark
The Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet
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Copenhagen, Zealand, Denmark
Anæstesiologisk afdeling, Vejle Sygehus
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Vejle, Denmark