A comparison of sevoflurane and nitrous oxide as inhalation agents for dental sedation

ISRCTN	ISRCTN54172738
DOI	https://doi.org/10.1186/ISRCTN54172738
Secondary identifying numbers	N0013122021

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 25/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Carol Boyle
Scientific

Sedation & Special Care Dentistry
F26 Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 7188
Email	abc@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A comparison of sevoflurane and nitrous oxide as inhalation agents for dental sedation
Study objectives	To assess whether sevoflurane/oxygen is a suitable alternative to nitrous oxide/oxygen sedation in the treatment of anxious adult dental patients presenting to a sedation clinic in a dental hospital.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oral Health: Anaesthesia/Sedation
Intervention	The level of patient's anxiety will be assessed then each patient will attend for two visits. On the first visit, patients will be given either nitrous oxide/oxygen or sevoflurane/oxygen, the choice being randomized. Patients will be given the alternative drug on the second visit. The operator will score the acceptability of sedation received. After a period of recovery, the patient will be asked to fill in a questionnaire about their experience of sedation.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sevoflurane and nitrous oxide
Primary outcome measure	The patient's vital signs will be recorded throughout the procedure and analysed and compared for the two sedative agents. This will give an indication of whether sevoflurane is a more acceptable agent for sedation both in terms of the operator and the patient.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2002
Completion date	31/07/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	25 patients to be selected from the dental hospital sedation clinic.
Key inclusion criteria	1. Adult who have some form of dental anxiety 2. American Society of Anesthesiologists (ASA) I/II 3. Can give valid consent. Patients must be escorted by a responsible adult on the days of the sedation procedures.
Key exclusion criteria	1 Pregnancy or possible pregnancy 2 Nursing mothers 3. Patients with heart conditions 4. History of allergy to sevoflurane or any related agents
Date of first enrolment	01/04/2002
Date of final enrolment	31/07/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's Hospital

London
SE1 9RT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Guy's and St Thomas' NHS Foundation Trust
Government organisation / Local government

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

25/03/2020: No publications found, all search options exhausted, study status unverified.