Prevention of agitation and pain after anaesthesia in children less than or equal to 1 year

Phase 2

Recruiting

• Conditions: Emergence agitation after anaesthesia

• Registration Number: 2024-520075-28-01
• Lead Sponsor: Rigshospitalet

Brief Summary

To evaluate the efficacy of clonidine for prevention of emergence agitation

To describe the pharmacokinetic parameters of clonidine when administered as a single dose intraoperatively

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 286

Inclusion Criteria

Paediatric patients (male and female), aged 3- ≤ 12 months

Scheduled 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

Exclusion Criteria

ASA >2

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)

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)

Bleeding requiring transfusion prior to scheduled anaesthesia

Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid

Malignant disease

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit).		Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit).
Pharmacokinetic parameter estimates for compartmental Clearance (CL), Volume of distribution (V) and T½		Pharmacokinetic parameter estimates for compartmental Clearance (CL), Volume of distribution (V) and T½

Secondary Outcome Measures

Name	Time	Method
The amount of additional opioid needed during stay in the postanaesthetic care unit (calculated as morphine equivalents) for treatment of postoperative pain		The amount of additional opioid needed during stay in the postanaesthetic care unit (calculated as morphine equivalents) for treatment of postoperative pain
No validated scale for assessment of PONV exists and PONV will be assessed by nausea/vomiting Yes or No. While vomiting is obvious, nausea may be considered to be present if the child refuses to eat and other causes are ruled out.		No validated scale for assessment of PONV exists and PONV will be assessed by nausea/vomiting Yes or No. While vomiting is obvious, nausea may be considered to be present if the child refuses to eat and other causes are ruled out.
The proportion of participants with 1) clinically relevant hypotension and, clinically relevant bradycardia, 2) clinically relevant bradycardia and clinically relevant apnoea.		The proportion of participants with 1) clinically relevant hypotension and, clinically relevant bradycardia, 2) clinically relevant bradycardia and clinically relevant apnoea.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen Oe, Denmark

Rigshospitalet

🇩🇰Copenhagen Oe, Denmark

Arash Afshari

Site contact

+4535458749

arash.afshari@regionh.dk