Effect of sedation on children`s behaviour

A clinical trial of comparison of intranasal midazolam and inhalation sedation (N2O/O2) on 3 to 6 year-old children`s behavior under dental treatments

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016111930971N1

Enrollment

Registered

2017-09-27

Start date

2011-12-31

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

behaviour.

Interventions

Intervention 1: Administeration of 0.5 mg/kg infusion midazolam via intranasal route in addition to inhalation sedation to the intervention group. Intervention 2: Administeration of 0.5 mg/kg infusi

Behavior

Administeration of 0.5 mg/kg infusion midazolam via intranasal route in addition to inhalation sedation to the intervention group

Administeration of 0.5 mg/kg infusion midazolam via intranasal route to the control group

Eligibility

Sex/Gender

All

Age

3 Years to 6 Years

Inclusion criteria

Inclusion criteria: No nasal obstruction; respiratory infection; limitation of neck movement; macroglosia; tonsil hypertension; micrognathia and limitation of mouth opening; ASA=1; at least two sessions needed including pulpotomy or filling of primary upper or lower molar; uncooperative children

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Behaviour. Timepoint: The same day. Method of measurement: Houpt scoring system.	—

Secondary

Measure	Time frame
Depth of sedation. Timepoint: Same day. Method of measurement: Houpt scoring system.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Nahid Askarizadeh

Dental branch, Islamic Azad University

n_asgarizadeh@dentaliau.ac.ir+98 21 8805 3043

Outcome results

None listed

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