Fasting versus non-fasting intravenous sedation in the dental setting

ISRCTN ISRCTN13385593
DOI https://doi.org/10.1186/ISRCTN13385593
Secondary identifying numbers 224757
Submission date
14/07/2017
Registration date
11/08/2017
Last edited
11/08/2017
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

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

Contact information

Dr Vasileios Lyris
Scientific

24/6 Clerk Street
Edinburgh
EH8 9HX
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleFasting versus non-fasting prior to intravenous sedation in the dental setting: a single-blinded randomised trial
Study objectivesPatients who are not fasting have fewer complications than those fasting.
Ethics approval(s)Not provided at time of registration - submission pending
Health condition(s) or problem(s) studiedIntravenous sedation in the dental setting
InterventionThe 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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date18/09/2017
Completion date06/03/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants732 in two groups of 366 each
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/09/2017
Date of final enrolment06/02/2020

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centres

Edinburgh Dental Institute
Edinburgh
EH3 9HA
United Kingdom
Chalmers Dental Centre
Edinburgh
EH3 9EW
United Kingdom

Sponsor information

The Queen's Medical Research Institute
Hospital/treatment centre

c/o Mr Chris Conner
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Website http://accord.scot/
ROR logo "ROR" https://ror.org/01nrxwf90

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date06/03/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal within 12 months of the completion of the trial.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.