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The PREVENT AGITATION trial II – children ≤1 year

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520075-28-01
Enrollment
286
Registered
2025-01-29
Start date
2021-10-22
Completion date
Unknown
Last updated
2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence agitation after anaesthesia

Brief summary

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

Detailed description

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., The proportion of participants with 1) clinically relevant hypotension and, clinically relevant bradycardia, 2) clinically relevant bradycardia and clinically relevant apnoea.

Interventions

DRUGCatapresan 150 mikrogram/ml injektionsvätska
DRUGlösning
DRUGSODIUM CHLORIDE

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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., The proportion of participants with 1) clinically relevant hypotension and, clinically relevant bradycardia, 2) clinically relevant bradycardia and clinically relevant apnoea.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026