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.
Conditions
Interventions
Pharmaceutical Form: Nasal spray
Trade Name: Natriumklorid 4,5mg/ml
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Nasal use
Sponsors
Oulu university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study Are the trial subjects under 18? yes Number of subjects for this age range: 112 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria include: -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 PICU -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 A single patient can only participate in this study once.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points include: -The duration of the procedure -Parents assessment of the patients comfortability during the procedure -Patients assessment of the experienced pain with Visual Analog Scale -Assessment of pain levels of the patient with FLACC-scores -Assessment of sedation levels of the patient with Comfort-B-scores -Duration of crying -The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo -Blood pressure is measured by manometer -Respiratory rate is assessed by capnometry -Oxygen saturation is measured by pulse oxymetry -Heart rate is measured by ECG;Timepoint(s) of evaluation of this end point: The vital parameters, FLACC-scores, sedation level are evaluated in every 5 minutes starting 10 minutes before the administration of the drug and continuing until 2 hours of the administration of study drug or the patient has completely woken up. VAS scores are asked after the patients have woken up. The parents and the nurses assessment of the pain levels are asked after the procedure. | — |
Countries
Finland
Contacts
Public ContactLasten ja nuorten klinikka
Oulu University Hospital
Outcome results
None listed