Premedication with Intravenous Midazolam for Neonatal Endotracheal Intubation

Comparison of the Effect of Atropine Alone and in Combination with Midazolam on the Prevention of Pain of Endotracheal Intubation in Premature Neonates with Respiratory Distress

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130329012869N2

Enrollment

105

Registered

2020-06-09

Start date

2019-07-02

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

pain during endotracheal intubation.

Interventions

Intervention 1: Intervention group:Injection of 150 microgram per kilogram midazolam intravenously in 5 minute and injection of 10 microgram per kilogram atropine intravenously 5 minute perior to in

Eligibility

Sex/Gender

All

Age

1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Gestational age of less than 37 weeks Presence of respiratory distress syndrome and the need for nasal continuous positive airway pressure (Nasal CPAP)with a fraction of inspired oxygen (Fio2)of at least 40% to maintain arterial oxygen saturation between 90 to95% To be a candidate for surfactant treatment with Intubation Surfactant Rapid Extubation ( INSURE) method

Exclusion criteria

Exclusion criteria: Maxillofacial anomalies, congenital heart diseases Previous endotracheal intubation Twice or more failed attempts for intubation

Design outcomes

Primary

Measure	Time frame
Pain Score. Timepoint: Before intervention and immediatly after intubation. Method of measurement: Premature Infant Pain Profile (PIPP).	—

Secondary

Measure	Time frame
Heart Rate. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Arterial Blood Pressure. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Arterial Oxygen Saturation Percent. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Number of Attempts for Intubation. Timepoint: During the intubation. Method of measurement: Observation.;Duration of Intubation. Timepoint: During the intubation. Method of measurement: Timer.	—

Measure

Time frame

Heart Rate. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Arterial Blood Pressure. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Arterial Oxygen Saturation Percent. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Number of Attempts for Intubation. Timepoint: During the intubation. Method of measurement: Observation.;Duration of Intubation. Timepoint: During the intubation. Method of measurement: Timer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZohreh Badiee

Esfahan University of Medical Sciences

badiee@med.mui.ac.ir+98 31 3792 4572

Outcome results

None listed

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