Comparison of intranasal midazolam and ketamine in peripheral IV access in childre
- Conditions
- Pain and distress associated with peripheral IV access in children in emergency department.
- Registration Number
- IRCT20200728048242N1
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
1 to 10 years-old Children
Emergency department or wards admission
Needing IV access for diagnostic and therapeutic interventions
Patients with critical or emergency conditions, or in other words, have level 1 triage and are treated in the resuscitation room
All cases in which parents do not consent to sedation and analgesia prior to peripheral intravenous access
All patients with a history of allergies to ketamine or midazolam
Age less than one year or over 10 years
Existence of serious underlying heart disease including heart failure, electrical heart disorders, congenital heart defects
Presence of advanced liver or kidney disease, including renal failure or dialysis, history of kidney or liver transplantation, congenital metabolic disorders
Children with cerebral palsy, cystic fibrosis and epilepsy
Congenital or acquired jaw and facial abnormalities
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Observational Scale Of Behavioral distress-Revised Score. Timepoint: 20 min after intervention. Method of measurement: Observational Scale Of Behavioral distress-Revised (OSBD-R).;Success rate of accessing peripheral Intravenous line. Timepoint: 20 min after the intervention. Method of measurement: Researcher observation based on the presence or lack of physical restraint during the procedure.
- Secondary Outcome Measures
Name Time Method Heart Rate. Timepoint: 10 and 20 minutes after the intervention. Method of measurement: Portable Pulse Oximeter.;Oxygen Saturation. Timepoint: 10 and 20 minutes after the intervention. Method of measurement: Portable Pulse Oximeter.;Satisfaction of parents. Timepoint: Once after the end of the procedure. Method of measurement: 5 point likert scale.;Satisfaction of nurses. Timepoint: Once after the end of the procedure. Method of measurement: 5 point likert scale.