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Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psychomotor Agitation

Intervention: Clonidine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Steen Henneberg, MD, DMSc, Study Director, Affiliation: Rigshospitalet, Denmark

Overall contact:
Mogens H Ydemann, MD, Phone: +4531155995, Email: MD@ydemann.dk

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 dont have solid evidence for the effect and the investigators dont 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: postoperative agitation

Secondary outcome:

Fentanyl and morphine requirements

Pain assessment

First administration of Fentanyl or morphine

Serious adverse reactions/events

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.

Eligibility

Minimum age: 1 Year. Maximum age: 5 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Mogens H Ydemann, MD, Phone: +4531155995, Email: MD@ydemann.dk

The Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Zealand 2100, Denmark; Recruiting
Mogens H Ydemann, MD, Phone: +4531155995, Email: mogens@ydemann.dk
Arash Afshari, MD, PhD, Phone: +4535458749, Email: Arash.Afshari@regionh.dk
Additional Information

Related publications:

Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative α₂-adrenergic agonists on postoperative behaviour in children. Br J Anaesth. 2014 Jun;112(6):982-90. doi: 10.1093/bja/aeu093. Epub 2014 Apr 11. Review.

Starting date: January 2015
Last updated: February 6, 2015

Page last updated: August 20, 2015

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