Plain English Summary
Background and study aims
Dental anxiety is when patients feel nervous, worried or uneasy about going to the dentist. Almost one out of two patients suffer from moderate to severe dental anxiety. A very efficient, cost effective and low risk method to manage dental anxiety is conscious sedation. Conscious sedation is a combination of medicines to help patients relax (a sedative) and to block pain (an anesthetic) during a dental procedure. It is not known whether it is better to fast or not before sedation. This is due to lack of high quality evidence to effectively support one or the other. Further research will help to improve knowledge of the subject and provide better healthcare and treatment to patients by reducing the side effects of sedation. The aim of this study is to compare sedation-related complications, the dose of the sedation drug, and the recovery time needed after sedation in fasting and non-fasting patients.
Who can participate?
Patients aged 17-65 undergoing oral surgery under sedation
What does the study involve?
Participants are randomly allocated to either the fasting group or the non-fasting group. Sedation-related complications, the dose of the sedation drug, and the recovery time needed after sedation are compared between the two groups.
What are the possible benefits and risks of participating?
No additional benefits or risks are expected for the participants, but the results may help to develop guidelines that will benefit patients in the future.
Where is the study run from?
Edinburgh Dental Institute (EDI) and Chalmers Dental Centre (CDC) (UK)
When is the study starting and how long is it expected to run for?
September 2017 to March 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Vasileios Lyris
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
224757
Study information
Scientific title
Fasting versus non-fasting prior to intravenous sedation in the dental setting: a single-blinded randomised trial
Acronym
Study hypothesis
Patients who are not fasting have fewer complications than those fasting.
Ethics approval
Not provided at time of registration - submission pending
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Intravenous sedation in the dental setting
Intervention
The patient information sheet for this project is sent with the letter for the new patient appointment. Then when the patients are seen in the Edinburgh Dental Institute or the Chalmers Dental Centre for their new patients appointment, all potential participants planning to undergo IV sedation are given the patient information sheet (again) as well as the consent form and they are asked them if they are willing to participate. If the patient agrees to participate, he/she will sign the consent form and will be given an envelope with the "Fasting" or "Non-Fasting" instructions. Patients are randomised according to a randomisation sequence generated by www.randomizer.org.
1. The "Non-Fasting envelope" will advise the patients to eat normally on the day of their appointment, avoiding alcoholic drinks and large meals
2. The "Fasting envelope" will follow the 6-4-2 protocol which is: six hours prior to sedation for solid food, four hours for non-clear drinks (e.g. milk, orange juice, etc), and two hours for clear fluids like water
The patient will be advised to review more carefully the patient information sheet at home and 2-3 weeks prior to his/her sedation appointment will be contacted to re-confirm willingness to participate and get reminded of what to do according to the envelope that he/she has got. The surgical procedure may be performed by member or members of the research team, or any other clinician of the oral surgery team of the Edinburgh Dental Institute and Chalmers Dental Centre. The patients will be asked by the responsible clinician if they have fasted or not for safety reasons and in order to get the best possible care. After the surgical appointment, the clinical notes are going to be transferred in the Case Report Form, and the form is going to be locked away. All the data required to be completed in the Case Report Form is the pre-operative, intra-operative and post-operative data that is normally collected in the Edinburgh Dental Institute and Chalmers Dental Centre. The sedation drug used is the one used in the standard protocol, midazolam. For some patients, if deemed necessary the reversing agent might be needed to be used, flumazenil.
The duration of treatment is relative and it depends upon the waiting times for intravenous sedation appointments at the Edinburgh Dental Institute and Chalmers Dental Centre. These range from 2-3 months from the time of the new patient clinic appointment until the time of treatment.
The data will be analysed using Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). Descriptive statistics will be used to present mean values with standard deviations and 95% confidence intervals where appropriate. Independent t-tests will be used for continuous numerical and differences will be tested for statistical significance using the chi-squared x² test. Statistical significance will be defined as p<0.05. Patients that will drop out or patients with missing data will be excluded from the analyses but they will be mentioned in the discussion part of the study.
Intervention type
Other
Phase
Drug names
Primary outcome measures
The incidence of pre-operative (cannulation), intra-operative and post-operative (recovery) complications following intravenous sedation procedures, recorded using the Case Report Form on the day of the operation and until the time of discharge of the patient upon recovery
Secondary outcome measures
1. Dose of drug used (midazolam), recorded using the Case Report Form on the day of the operation
2. Recovery time, recorded using the Case Report Form at the time of discharge of the patient upon recovery
Overall trial start date
18/09/2017
Overall trial end date
06/03/2020
Reason abandoned
Eligibility
Participant inclusion criteria
1. NHS patients at Edinburgh Dental Institute (EDI) and Chalmers Dental Centre (CDC) planned to undergo oral surgery procedure under intravenous sedation
2. Aged 17-65
3. Classified as ASA I or ASA II
4. Male and female patients
5. Able to give consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
732 in two groups of 366 each
Participant exclusion criteria
1. Patients having general anaesthesia
2. Patients having procedures under local anaesthetic alone
3. Patient not able to give consent
4. ASA 3 and ASA 4
5. Patient not willing to participate
6. Patient unable to undertake sedation under midazolam
7. Patients unable to fast e.g. patients with type 1 diabetes mellitus or eating disorders
8. Patients taking St John’s Wort
Recruitment start date
18/09/2017
Recruitment end date
06/02/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Edinburgh Dental Institute
Edinburgh
EH3 9HA
United Kingdom
Trial participating centre
Chalmers Dental Centre
Edinburgh
EH3 9EW
United Kingdom
Sponsor information
Organisation
The Queen's Medical Research Institute
Sponsor details
c/o Mr Chris Conner
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal within 12 months of the completion of the trial.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
06/03/2021
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary