Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.

NCT06056492 | Completed

• 1 other identifier: ULeeds1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out the effect of experience of dental sedation at assessment on children's anxiety before the actual treatment session.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• Modified Child Dental Anxiety Scale

  Score 8-40. High score is high anxiety. Measured through MCDAS and E$ physiological wristband data

  At start of recruitment. 4 weeks. 4 weeks.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants assigned to the control group received assessment without experience N2O/O2 sedation and they tried the mask with O2 only.

Behavioral: Experience of nitrous oxide sedation at assessment

Study Group

EXPERIMENTAL

Participants assigned to the study group received assessment with experience of N2O/O2 sedation

Behavioral: Experience of nitrous oxide sedation at assessment

Interventions

Experience of nitrous oxide sedation at assessment BEHAVIORAL

Apart from the Lead researcher, a dental nurse assisted with the dental treatment on every appointment. A specially trained sedation nurse was responsible for the monitoring during sedation. The Porter Brown inhalation sedation machine (RA Services, Keighly, W. Yorkshire, UK) was used. Once the appropriate nasal hood was selected, 100% O2 was introduced for 1-2 minutes. Following that, the level of N2O was increased in 10% increments until signs of sedation were observed. The endpoint was between 30-40% nitrous oxide.

Control Group; Study Group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients attending the Sedation Unit for dental treatment under inhalation sedation.
• Children aged 5 to 15 years.
• ASA Class I or II.
• First time having inhalation sedation.

You may not qualify if:

• Participants who refuse to wear the mask.
• Language barriers where no interpreter was available
• Parents/Carer who refused to sign consent or children who did not assent.

Sponsors & Collaborators

• Dr Richard Balmer: lead

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LE2 9LU, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Paediatric Dentistry

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 28, 2023
• Study Start: March 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

GB (1)