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comparing nitrous oxide and hydroxyzine for reducing pain in cildren during dental anesthesia

Comparison of the Sedation Effect of Inhaled Nitrous Oxide and Oral Hydroxyzine on Pain Perception of 3–8-year Pediatric Dental Patients during Local Anesthesia Infiltration: A Cross-over Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250602066022N1
Enrollment
24
Registered
2025-06-21
Start date
2025-07-06
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

In this study, the pain perception of 3-8-year-old children will be studied while administering 2 interventions, Nitrous Oxide inhalation and oral Hydroxyzine.

Interventions

Intervention 1: Intervention group: Nitrous oxide: The nitrous oxide gas is to be administered according to the standard titration technique. A flow rate of five to seven liters per minute (L/min) is

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: ?-? years old children who have a FRANKL II score Children who have at least ? sessions of dental work requiring local anesthesia in same jaw considering that in each session the maximum number of treatments is to be done Children who are healthy with no medical history Children with no previous dental history

Exclusion criteria

Exclusion criteria: Children who are not in the ?–?-year age range Severe anxious children Children who have a drug allergy children whose parents don’t provide written informed consent children having acute otitis media, active pulmonary infection, nasal obstruction cooperative children having FRANKL IV score

Design outcomes

Primary

MeasureTime frame
Pain perception during local anesthetic infiltration. Timepoint: the effect of the 2 interventions will be measured during the injection of local anesthesia infiltration. Method of measurement: in this study, comparing the effect of nitrous oxide inhalation and oral hydroxyzine on reducing pain perception of 3-8 year old children during local anesthesia infiltration. The outcome variable is to be measured using the FLACC scale. The FLACC scale will be measured during the anesthesia injection. A video is to be taken during the anesthesia injection, so that 2 observers will measure the FLACC separately.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHanan AlHousseini

Tehran University of Medical Sciences

hanan_alhousseini@hotmail.com+98 21 6642 7824

Outcome results

None listed

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