Evaluation of the effect of oral chloral hydrate and intranasal midazolam on sedation of children

Comparison of Sedative Effect of Intranasal Midazolam Spray and Chloral Hydrate in Children with Head Trauma for Imaging in Emergency Department

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180129038549N4

Enrollment

160

Registered

2018-04-11

Start date

2017-09-23

Completion date

Unknown

Last updated

2018-05-21

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

Conditions

Head trauma. Superficial injury of head

Interventions

Intervention 1: Control group: Syrup chloral hydrate 75 mg / kg and placebo intranasal. Intervention 2: Intervention group: Intranasal midazolam 0.3 mg / kg and oral placebo.

Eligibility

Sex/Gender

All

Age

1 Years to 8 Years

Inclusion criteria

Inclusion criteria: The child is alert with head trauma requires CT scan of head Lack of cooperation for CT scan American Society ofAnesthesiology (ASA) class 1 or 2

Exclusion criteria

Exclusion criteria: Receiving a sedative hypnotic agent within thepast 48 hours Gastritis Serious systemic disease Nasal allergy to drugs Obesity (body mass index.30) Known contraindications to theuse of study drugs (eg, hypersensitivity),

Design outcomes

Primary

Measure	Time frame
Sedation level of the patient. A score of four is considered. Timepoint: Every 5 minutes. Method of measurement: Physical exam.;Success in CT scan doing. Timepoint: After refer to the radiology department. Method of measurement: Performing or not performing a CT scan.	—

Secondary

Measure	Time frame
Side effects. Timepoint: every 5 minutes. Method of measurement: Physical exam.;Vital signs (blood oxygen saturation level, pulse rate and respiratory rate per minute). Timepoint: Every 5 minutes. Method of measurement: Physical exam.;The time interval from taking the drugs to the adequate sedation. Timepoint: Every 5 minutes. Method of measurement: Ramsay sedation scale.;The interval time between drug taking and CT scan performing. Timepoint: Every 5 minutes. Method of measurement: Record time.;The time interval from taking the drug to the child's full consciousness. Timepoint: Every 5 minutes. Method of measurement: Record time.;The parents' satisfaction. Timepoint: After the child's consciousness. Method of measurement: Question from parents.	—

Measure

Time frame

Side effects. Timepoint: every 5 minutes. Method of measurement: Physical exam.;Vital signs (blood oxygen saturation level, pulse rate and respiratory rate per minute). Timepoint: Every 5 minutes. Method of measurement: Physical exam.;The time interval from taking the drugs to the adequate sedation. Timepoint: Every 5 minutes. Method of measurement: Ramsay sedation scale.;The interval time between drug taking and CT scan performing. Timepoint: Every 5 minutes. Method of measurement: Record time.;The time interval from taking the drug to the child's full consciousness. Timepoint: Every 5 minutes. Method of measurement: Record time.;The parents' satisfaction. Timepoint: After the child's consciousness. Method of measurement: Question from parents.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarhad Heydari

Esfahan University of Medical Sciences

drfarhadheydari@gmail.com+98 31 3776 9818

Outcome results

None listed

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