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Comparison of intranasal midazolam and ketamine in peripheral IV access in children

Comparison of clinical efficacy of Intranasal administration of midazolam and ketamine in managing pain and distress associated with peripheral IV access in children presenting to emergency departments of IUMS

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200728048242N1
Enrollment
100
Registered
2020-08-10
Start date
2019-03-21
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and distress associated with peripheral IV access in children in emergency department.

Interventions

Intervention 1: Intervention group 1: Intranasal ketamine administration, at a dose of 5 mg/kg from a 50 mg/cc ketamine ampule, produced by Rotexmedica, Germany, twenty minutes before peripheral intra

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1 to 10 years-old Children Emergency department or wards admission Needing IV access for diagnostic and therapeutic interventions

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactIman Mehrabi

Iran University of Medical Sciences

Imannnehrabi@gmail.com+98 11 5422 1337

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026