Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carol Boyle

ORCID ID

Contact details

Sedation & Special Care Dentistry
F26 Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 7188
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013122021

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Sevoflurane and nitrous oxide

Primary outcome measures

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 trial start date

01/04/2002

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

25 patients to be selected from the dental hospital sedation clinic.

Participant 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

Recruitment start date

01/04/2002

Recruitment end date

31/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's Hospital
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Guy's and St Thomas' NHS Foundation Trust

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes