Prevention of agitation and pain after anaesthesia in children aged 1 year and below

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 20.1Level: LLTClassification code 10079742Term: Agitation on recovery from sedationSystem Organ Class: 100000004863; Emergence agitation

• Registration Number: EUCTR2020-005409-26-DK
• Lead Sponsor: Copenhagen University Hospital, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-16
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• Paediatric patients, age 3 = 12 months
• Scheduled for general anaesthesia with sevoflurane and opioid. Induction with propofol is optional
• The legally acceptable representative for the study participant provides written informed consent/assent for the trial
Are the trial subjects under 18? yes
Number of subjects for this age range: 336
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• ASA >2
• Cardiac, neuro and trauma surgery
• Ex-premature (<37 weeks)
• Premedication with clonidine
• Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure
• Critical illness incl. hemodynamic instability (inotropic drugs needed)
• Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid
• Bleeding requiring transfusion prior to scheduled anaesthesia
• Malignant disease
• Cardiac disease incl. arrhythmia
• Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient
• Mental retardation
• Neurological disease including symptoms similar to emergence agitation
• Has or is suspected of having a family or personal history of malignant hyperthermia
• Has or is suspected of having an allergy to study treatment or its excipients
• Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data
• Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified