Comparison between the effect of oral chloral hydrate and intranasal Fentanyl on sedation

Comparison between the effect of oral chloral hydrate and intranasal Fentanyl on pediatric sedation for EEG .

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191205045618N1

Enrollment

Registered

2020-03-16

Start date

2019-12-22

Completion date

Unknown

Last updated

2020-03-24

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

Conditions

mean arterial pressure,o2 saturation,heart rate, respiratory rate ,degree of sedation by RAMSEY scale.

Interventions

Intervention 1: Intervention group: first group gets 50mg/kg oral chloral hydrate ,30 minutes before EEG and 2µg/kg intra nasal normal saline as placebo. Intervention 2: Intervention group: 2nd group

Eligibility

Sex/Gender

All

Age

3 Months to 3 Years

Inclusion criteria

Inclusion criteria: children between 3 months to years candidated for EEG

Exclusion criteria

Exclusion criteria: cancelling of EEG after administration of drug drug allergy respiratory problems

Design outcomes

Primary

Measure	Time frame
Mean arterial pressure. Timepoint: before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery. Method of measurement: monitoring by manometer.;Heart rate. Timepoint: before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery. Method of measurement: monitoring by palseoxymeter.;Degree of sedation. Timepoint: before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery. Method of measurement: RAMSEY scale.	—

Measure

Time frame

Mean arterial pressure. Timepoint: before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery. Method of measurement: monitoring by manometer.;Heart rate. Timepoint: before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery. Method of measurement: monitoring by palseoxymeter.;Degree of sedation. Timepoint: before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery. Method of measurement: RAMSEY scale.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Shafa

Esfahan University of Medical Sciences

amir_shafa@med.mui.ac.ir+98 31 3386 9141

Outcome results

None listed

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