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
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