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Analgesia and sedation to guarantee painful venous access in children not intubated.

Analgesia and sedation for procedures in pediatric patients on spontaneous ventilation: a randomized controlled trial comparing the combination ketamine and dexmedetomidine versus usual care (ASSURE Study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5gwknk
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-07-13
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Cardiovascular diseases

Interventions

Intervention group: Ketamine bolus 1mg/kg and Dexmedetomidine 1mcg/kg in 3 minutes, followed by continuous infusion of dexmedetomidine 0.5 mcg/kg/h. If necessary, additional doses of ketamine 1mg/kg m
Drug
E03.091
E03.250
N02.421.585.525

Sponsors

Hospital Universitario da Universidade de São Paulo
Lead Sponsor
Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
1 Months to 18 Years

Inclusion criteria

Inclusion criteria: To compare the success rates of invasive procedures, such as the insertion of a central venous catheter and peripherally inserted central venous catheter in children on spontaneous ventilation with the use of the combination ketamine and dexmedetomidine versus usual care (habitual sedoanalgesia performed in each of the participating units).

Exclusion criteria

Exclusion criteria: Patients in whom the passage of central venous catheter or peripherally inserted central venous catheter receiving invasive ventilatory care, those receiving sedoanalgesia (except with dipyrone, paracetamol and anti-inflammatory) and those with contraindications to the drugs studied were indicated. Patients who did not have the free and informed consent form signed by their parents or guardians.

Design outcomes

Primary

MeasureTime frame
success rates of invasive procedures—

Secondary

MeasureTime frame
Describe the analgesic and sedative effects of the combination ketamine and dexmedetomedine and compare to the usual care control group; ; Describe and compare possible adverse effects, such as: hemodynamic and respiratory repercussion between the two groups;;Describe and compare the time to perform the procedure between the two groups;;Describe and compare the number of additional doses of sedatives required to maintain sedation;Describe and compare the cost between the two groups.—

Countries

Brazil

Contacts

Public ContactAna Lucia Bianchini

Hospital Universitario da Universidade de São Paulo

analucia.pediatria@gmail.com+55 (14) 991955242

Outcome results

None listed

Source: REBEC (via WHO ICTRP)