Controling of pain and stress associated with peripheral venous thrombosis in children

Comparison of three methods of verbal speaking intranasal injection of midazolam and ketamine intranasal injection in control of pain and stress associated with peripheral venous thrombosis in children

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151003024317N8

Enrollment

100

Registered

2019-09-28

Start date

2019-10-02

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Peripheral vein in children.

Interventions

Intervention 1: Intervention group: Intranasal injection of Midazolam 0.2 mg / kg, 20 minutes before the procedure with the MAD. Intervention 2: Intervention group: Intranasal injection of Ketamine 5

Eligibility

Sex/Gender

All

Age

1 Years to 10 Years

Inclusion criteria

Inclusion criteria: Age over one year Parental consent for the child to participate in the project

Exclusion criteria

Exclusion criteria: Immunodeficiency Down syndrome Chronic heart and pulmonary disease

Design outcomes

Primary

Measure	Time frame
Saturation of oxygen. Timepoint: 10 minutes after the procedure. Method of measurement: Pulse Oximetry.;The number of pulses. Timepoint: 10 minutes after the procedure. Method of measurement: Based on patient records.;Breath rate. Timepoint: 10 minutes after the procedure. Method of measurement: Based on patient records.;The severity of pain after the procedure. Timepoint: 10 minutes after the procedure. Method of measurement: Observational Scale of Behavioral Distress-Revised.;The amount of sedation. Timepoint: 10 minutes after the procedure. Method of measurement: Observational Scale of Behavioral Distress-Revised.	—

Measure

Time frame

Saturation of oxygen. Timepoint: 10 minutes after the procedure. Method of measurement: Pulse Oximetry.;The number of pulses. Timepoint: 10 minutes after the procedure. Method of measurement: Based on patient records.;Breath rate. Timepoint: 10 minutes after the procedure. Method of measurement: Based on patient records.;The severity of pain after the procedure. Timepoint: 10 minutes after the procedure. Method of measurement: Observational Scale of Behavioral Distress-Revised.;The amount of sedation. Timepoint: 10 minutes after the procedure. Method of measurement: Observational Scale of Behavioral Distress-Revised.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShabahang Jafarnejad

Iran University of Medical Sciences

shabahangjafarnejad@yahoo.com+98 21 86701

Outcome results

None listed

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