Intranasal dexmedetomidine sedation and analgesia during pediatric emergency room procedures

Phase 4

Not yet recruiting

Conditions: Patients of the pediatric emergency room at Oulu University Hospital with any medical condition requiring a minor painful procedure such as i.v. cannulation or lumbar puncture are asked to join our study if they would seem to benefit from a sedative drug during the procedure.

Brief Summary: Our objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room.

Recruitment & Eligibility

Inclusion Criteria

Age 1-12 years

Small procedure (e.g. i.v. cannulation or lumbar puncture)

Presents at the Oulu University Hospital emergency room

Exclusion Criteria

Allergy to dexmedetomidine or any supplementary elements of the dexmedetomidine-solution

II or III degree AV-blockage without pacemaker

Uncontrollable hypotension

Stroke

Critically ill patients who are admitted to the Pediatric Intensive Care Unit

Patients with clear cardiac or respiratory dysfunction

Lowered level of consciousness

Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity

Prior participation to the current study

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary end point in this study is the success of the procedure at the first attempt.;Timepoint(s) of evaluation of this end point: The success rate of the first attempt of the procedure is evaluated at the end of the first attempt of the procdure.;Main Objective: Our objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. ;Secondary Objective: The duration of sedative effects of 1µg/kg intranasal dexmedetomidine spray is assessed.
The success of the procedure at the first attempt		The success of the procedure at the first attempt

Secondary Outcome Measures

Name	Time	Method
The duration of the procedure		The duration of the procedure
Parents assessment of the patients comfortability during the procedure		Parents assessment of the patients comfortability during the procedure
Patient's and physician's assessment of the experienced pain with Visual Analog Scale		Patient's and physician's assessment of the experienced pain with Visual Analog Scale
Assessment of pain levels of the patient with FLACC-scores		Assessment of pain levels of the patient with FLACC-scores
Assessment of sedation levels of the patient with Comfort-B-scores		Assessment of sedation levels of the patient with Comfort-B-scores
Duration of crying		Duration of crying
The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo		The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo
Blood pressure measured by manometer		Blood pressure measured by manometer
Respiratory rate assessed by capnometry		Respiratory rate assessed by capnometry
Oxygen saturation is measured by pulse oxymetry		Oxygen saturation is measured by pulse oxymetry
Heart rate measured by ECG		Heart rate measured by ECG

Locations (1): Oulu University Hospital
🇫🇮
Oulu, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Outi Peltoniemi
Site contact
+35883155837
outi.peltoniemi-ailisto@pohde.fi

RecruitingPhase 4

Posted 6/20/2018

Updated 12/20/2023