A comparison of sevoflurane and nitrous oxide as inhalation agents for dental sedation
| ISRCTN | ISRCTN54172738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54172738 |
| Protocol serial number | N0013122021 |
| Sponsor | Department of Health (UK) |
| Funder | Guy's and St Thomas' NHS Foundation Trust |
- 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
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 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sevoflurane and nitrous oxide |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 31/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 25 |
| 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
- United Kingdom
- England
Study participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/03/2020: No publications found, all search options exhausted, study status unverified.
