Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

NCT02361476 | Completed Phase 4 Results DMC

• 1 other identifier: H - 2 - 2014 - 072
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 3

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.

Conditions

Psychomotor Agitation

Keywords

Anaesthesia; Children; Clonidine; Sevoflurane; Postoperative agitation; Prevention; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (1)

• Postoperative Agitation

  Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated

  1 day

Secondary Outcomes (4)

• Fentanyl and Morphine Requirements

  Recorded during the stay in the postoperative recovery room

• Pain Assessment

  recovery room - hours

• First Administration of Fentanyl or Morphine

  recovery room

• Adverse Events

  from intervention to discharge from the recovery room

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Clonidine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Clonidine DRUG

Injection - during surgery

Also known as: catapresan

Intervention

Placebo DRUG

Injection - during surgery

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (3)

The Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Region Sjælland, 2100, Denmark

Location

Køge Sygehus, Anæstesiologisk Afdeling

Køge, 4600, Denmark

Location

Anæstesiologisk afdeling, Vejle Sygehus

Vejle, 7100, Denmark

Location

Related Publications (3)

• Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative alpha(2)-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.

  PMID: 24727829 BACKGROUND

• Ydemann M, Nielsen BN, Henneberg S, Jakobsen JC, Wetterslev J, Lauritsen T, Steen N, Edstrom B, Afshari A; PREVENT AGITATION Research Group. Intraoperative clonidine for prevention of postoperative agitation in children anaesthetised with sevoflurane (PREVENT AGITATION): a randomised, placebo-controlled, double-blind trial. Lancet Child Adolesc Health. 2018 Jan;2(1):15-24. doi: 10.1016/S2352-4642(17)30127-X. Epub 2017 Nov 2.

  PMID: 30169192 DERIVED

• Ydemann M, Nielsen BN, Wetterslev J, Henneberg S, Lauritsen T, Steen N, Edstrom B, Afshari A. Effect of clonidine to prevent agitation in children after sevoflurane anaesthesia: a randomised placebo controlled multicentre trial. Dan Med J. 2016 Jun;63(6):A5234.

  PMID: 27264945 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mogens Ydemann, MD
• Organization: Rigshospitalet

mogens@ydemann.dk

+45 35455620

Study Officials

• Steen Henneberg, MD, DMSc

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 1, 2015
• First Posted: February 11, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2018-09

Locations

DK (3)