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

Sponsor

Dr Richard Balmer (Other)

Overall Status

Completed

CT.gov ID

NCT06056492

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety	Behavioral: Experience of nitrous oxide sedation at assessment	N/A

Detailed Description

Title: Effectiveness of children experiencing nitrous oxide/oxygen inhalation sedation at an assessment visit before having treatment.

Background: Dental anxiety is a common problem, affecting people of all ages, but predominantly children and adolescents. Inhalation sedation (IHS) using nitrous oxide/oxygen (N2O/O2) mixture is a pharmacological behaviour management technique that is widely used to manage dental anxiety in children. It is suggested that the use of an acclimatisation would increase the acceptability and the efficacy of N2O/O2 success. Even though the introductory appointment has been widely proposed, there have not been any studies conducted to measure the effectiveness of this appointment in improving the success of N2O/O2 sedation in children.

Aims: This study aimed to investigate the effect of experience of nitrous oxide/oxygen sedation at assessment prior to dental inhalation sedation on children's anxiety.

Methods: The study was a parallel randomised non blinded control clinical trial. Children aged five to fifteen years who were seen at the Leeds Dental Institute for dental treatment under inhalation sedation were recruited on the assessment appointment (1st visit). Both two groups received an assessment appointment, however participants of the study group tried on the mask and the nitrous oxide/oxygen sedation while the ones of the control group tried on the mask without the nitrous oxide/oxygen sedation. Following the assessment appointment, both groups received a second appointment for treatment. Dental anxiety was measured through two different methods. Primarily through the MCDASf questionnaire, which was completed once at the beginning of the assessment visit and twice at the beginning and end of the treatment visit. Secondarily anxiety was measured though the E4 wristband which participants of both groups wore throughout both appointments and recorded their Heart Rate (HR) and Skin Temperature (ST). At the end of the treatment visit, participants and their parents/legal guardians were asked to complete a feedback questionnaire related to the E4 wristband and the experience of N2O/O2 sedation at the assessment visit.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group 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 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.
Experimental: Study Group Participants assigned to the study group received assessment with experience of N2O/O2 sedation	Behavioral: Experience of nitrous oxide sedation at assessment 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.

Arm

Intervention/Treatment

Active Comparator: Control Group

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

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.

Experimental: Study Group

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

Behavioral: Experience of nitrous oxide sedation at assessment

Outcome Measures

Primary Outcome Measures

Modified Child Dental Anxiety Scale [At start of recruitment. 4 weeks. 4 weeks.]
Score 8-40. High score is high anxiety. Measured through MCDAS and E$ physiological wristband data

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Leeds	Leeds	West Yorkshire	United Kingdom	LE2 9LU

Sponsors and Collaborators

Dr Richard Balmer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Richard Balmer, Associate Professor Paediatric Dentistry, University of Leeds

ClinicalTrials.gov Identifier:

NCT06056492

Other Study ID Numbers:

ULeeds1

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Aspiration

Nitrous Oxide

Study Results

No Results Posted as of Sep 28, 2023