Fasting versus Non-fasting IV Sedation in the Dental Setting
Research type
Research Study
Full title
Fasting versus non-fasting prior to intravenous sedation in the dental setting: A single blinded randomised trial.
IRAS ID
224757
Contact name
Julie L Burke
Contact email
ISRCTN Number
ISRCTN13385593
Duration of Study in the UK
2 years, 5 months, 19 days
Research summary
Almost 50% of patients suffer from moderate to severe dental anxiety. A very efficient, cost effective and low risk method to manage dental anxiety, is conscious sedation. Authoritative regulatory bodies through the United Kingdom such as the Scottish Dental Clinical Effectiveness Programme, the National Institute for Health and Care Excellence or the Royal Colleges of Surgeons and Royal College of Anaesthetists have failed to agree in their guidelines concerning fasting or non-fasting prior to intravenous sedation. This is in part due to lack of high quality evidence to support effectively one opinion or the other. Further research will help to improve our knowledge on the subject and provide better health care and treatment to patients through reduction of side effects.
In the present study we are planning to have two groups of 366 patients each, one fasting and one non-fasting. The aim is to compare the sedation related complications, the dose of the sedation drug (midazolam) dose, and the recovery time needed after sedation.
The patients will be recruited by the lead clinicians of each new patient clinic of the Edinburgh Dental Institute and Chalmers Dental Centre. Almost every patient suitable for sedation should be eligible for the study.
The eligible patients, will be given a patient information sheet and a consent form, and the ones that are willing to participate will be given an envelope containing the fasting or non-fasting label and the appropriate instructions to be followed. The participants are also going to be contacted 2 weeks before their sedation appointment to verbally re-consent and get reminded of what they should do.
After the sedation appointment, the research team will collect and analyse the data.
The research has no funding.REC name
South East Scotland REC 01
REC reference
17/SS/0131
Date of REC Opinion
12 Oct 2017
REC opinion
Favourable Opinion