Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

Psychomotor Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361476
• Other study ID #: H - 2 - 2014 - 072
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation

Intervention

Drug:
• Clonidine
Injection - during surgery
• Placebo
Injection - during surgery

Locations

Country	Name	City	State
Denmark	The Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet	Copenhagen	Zealand
Denmark	Køge Sygehus, Anæstesiologisk Afdeling	Køge
Denmark	Anæstesiologisk afdeling, Vejle Sygehus	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative a2-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Agitation	Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated	1 day
Secondary	Fentanyl and Morphine Requirements	Amount used	Recorded during the stay in the postoperative recovery room
Secondary	Pain Assessment	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
Secondary	First Administration of Fentanyl or Morphine	Time to administration	recovery room
Secondary	Adverse Events		from intervention to discharge from the recovery room