Clinical trial • Phase IV • Other

DEXMEDETOMIDINE for Procedural sedation

Phase IV trial of DEXMEDETOMIDINE for Procedural sedation. None/Not specified-controlled. 100 participants.

Overview

None/Not specified-controlled Phase IV trial in Belgium.

Recruits 100 paediatric patients.

Vulnerable Population: Paediatric participants are included (age 6 months - 12 years). Subject information and informed consent forms are provided for children and adults (documents listed: 'L1_SIS and ICF children 6-12 yr Dutch', 'L1_SIS and ICF children 4-6 yr Dutch', 'L1_SIS and ICF adults English', 'L1_SIS and ICF adults Dutch').

{"criterion_text":"- Age 6 months - 12 years\n- Weight < 30 kg\n- Indication for non-invasive radiological procedure\n- ASA I or II"}

{"criterion_text":"- Age < 6 months\n- Acute cerebrovascular conditions\n- ASA III or IV status\n- Hepatic abnormalities\n- Central nervous system dysfunction\n- Spinal cord injuries\n- Respiratory dysfunction\n- Increased pulmonary artery pressure\n- Renal dysfunction\n- Septic shock\n- Risk of difficult intubation\n- Age > 12 years\n- Hypersensitivity to any of the substances of the product\n- Drug allergy\n- Grade 2 or 3 heart block (unless paced)\n- Taking medicine with rate slowing action on AV-node? For example: digoxin, beta-adrenergic blockers, calcium channel blockers, monoamine oxidase inhibitor or other agents that predispose to bradycardia or hypotension\n- Uncontrolled chronic hypertension/hypotension\n- Congenital cardiac problems\n- Decreased cardiac output"}

{"endpoint_text":"- Success rate after one dose of intranasal dexmedetomidine","definition_or_measurement_approach":""}

{"endpoint_text":"- Success rate after an additional dose of intranasal dexmedetomidine (when adequate sedation is not reached after the first dose)","definition_or_measurement_approach":""}
{"endpoint_text":"- Time to the onset of sedation after the first administration of intranasal dexmedetomidine (minutes)","definition_or_measurement_approach":""}
{"endpoint_text":"- Duration of the sedation (minutes)","definition_or_measurement_approach":""}
{"endpoint_text":"- Duration of the procedure (minutes)","definition_or_measurement_approach":""}
{"endpoint_text":"- Waiting time until procedure (minutes)","definition_or_measurement_approach":""}
{"endpoint_text":"- Total length of hospital stay (minutes)","definition_or_measurement_approach":""}
{"endpoint_text":"- Prevalence of side effects","definition_or_measurement_approach":""}

Planned Sample Size: 100
Recruitment Window Months: 12
Consent Approach: Subject information and informed consent forms are provided for children and adults (documents present: 'L1_SIS and ICF children 6-12 yr Dutch', 'L1_SIS and ICF children 4-6 yr Dutch', 'L1_SIS and ICF adults English', 'L1_SIS and ICF adults Dutch').

Investigational Product Name: Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion
Active Substance: DEXMEDETOMIDINE
Modality: Small molecule
Routes Of Administration: INTRANASAL USE
Route: Intranasal
Authorisation Status: Authorised (marketing authorisation PL 03551/0161)
Dose Levels: Additional dose: 1 µg/kg
Maximum Dose: 200 µg
Dose Escalation Increase: Initial dose not specified; additional dose 1 µg/kg

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