DEXMEDETOMIDINE for Procedural sedation | Procedural pain

Inclusion criteria

• {"criterion_text":"- Age 1-12 years\n- Small procedure (e.g. i.v. cannulation or lumbar puncture)\n- Presents at the Oulu University Hospital emergency room"}

Exclusion criteria

• {"criterion_text":"- Allergy to dexmedetomidine or any supplementary elements of the dexmedetomidine-solution\n- II or III degree AV-blockage without pacemaker\n- Uncontrollable hypotension\n- Stroke\n- Critically ill patients who are admitted to the Pediatric Intensive Care Unit\n- Patients with clear cardiac or respiratory dysfunction\n- Lowered level of consciousness\n- Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity\n- Prior participation to the current study"}

Primary endpoints

• {"endpoint_text":"- The success of the procedure at the first attempt","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- The duration of the procedure","definition_or_measurement_approach":""}
• {"endpoint_text":"- Parents assessment of the patients comfortability during the procedure","definition_or_measurement_approach":"Parents' assessment using a Likert scale (as indicated in translations)."}
• {"endpoint_text":"- Patient's and physician's assessment of the experienced pain with Visual Analog Scale","definition_or_measurement_approach":"Pain assessed by patient and physician using Visual Analog Scale (VAS)."}
• {"endpoint_text":"- Assessment of pain levels of the patient with FLACC-scores","definition_or_measurement_approach":"Pain assessed using FLACC score."}
• {"endpoint_text":"- Assessment of sedation levels of the patient with Comfort-B-scores","definition_or_measurement_approach":"Sedation assessed using the COMFORT-B sedation scale."}
• {"endpoint_text":"- Duration of crying","definition_or_measurement_approach":"Measured in minutes from the moment the patient receives the intranasal study drug until the procedure is successfully completed."}
• {"endpoint_text":"- The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo","definition_or_measurement_approach":"Parental and nurse assessment of perceived treatment allocation (experimental drug vs placebo)."}
• {"endpoint_text":"- Blood pressure measured by manometer","definition_or_measurement_approach":"Blood pressure measurement by manometer."}
• {"endpoint_text":"- Respiratory rate assessed by capnometry","definition_or_measurement_approach":"Respiratory rate measured by capnometry."}
• {"endpoint_text":"- Oxygen saturation is measured by pulse oxymetry","definition_or_measurement_approach":"Oxygen saturation measured by pulse oximetry."}
• {"endpoint_text":"- Heart rate measured by ECG","definition_or_measurement_approach":"Heart rate measured by ECG."}

Methods

• Patients presenting to the Oulu University Hospital pediatric emergency room who require a minor painful procedure (e.g. IV cannulation or lumbar puncture) are approached and asked to join the study at the point of care in the emergency room (site: Finland, Oulu University Hospital).

Finland

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

05-11-2024

Processing Time Days

18

Number Of Sites

1

Number Of Participants

112

Primary sponsor

Full Name

Oulu University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland