Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psychomotor Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Clonidine : injection og 3 micg/kg IV during the operation.

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

Injection - during surgery

Placebo

Placebo : injection og equal amount of NaCl IV during the operation.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Injection - during surgery

Interventions

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Clonidine

Injection - during surgery

Intervention Type DRUG

Placebo

Injection - during surgery

Intervention Type DRUG

Other Intervention Names

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catapresan NaCl

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No