Salivary cortisol in sedated children version 1
Research type
Research Study
Full title
Salivary cortisol levels in children during dental treatment under conscious sedation with oral midazolam- a feasibility study.
IRAS ID
166320
Contact name
Marie Therese Hosey
Contact email
Clinicaltrials.gov Identifier
15/SW/0037, REC
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Child dental anxiety is difficult to measure accurately, and relies mainly on direct observation of behaviour. Therefore, it isn’t easy to exactly measure the benefit a sedative might have. When anyone is anxious or stressed the body produces a natural steroid- Cortisol. Technology advances now allows researchers to sample cortisol levels via saliva, obtained by a sample of spit or from a wet dental cotton roll.
Aim: To test the feasibility of using salivary cortisol as a means of assessing the anxiety level, and changes during dental treatment under sedation.
Research questions:
• Is it possible to collect saliva samples from these children?
• How does the cortisol level link with the standard observer anxiety measures?
• How many patient samples will be needed for future sedation studies?
Design: Prospective cohort- a feasibility study
Participants: Forty children already scheduled for dental treatment under oral sedation at KCH, recruited at the time of the new patient clinic appointment where the need for oral sedation has been determined or by telephone one week prior to the oral sedation appointment visit.
Method: Saliva samples will be via cotton wool rolls placed in the mouth of the child for 1-2 minutes until soaked with saliva and the hands with glove. Three samples of saliva will be collected during the visit, upon the child's arrival for dental treatment in the waiting room before drinking oral midazolam, 25 minutes after local anaesthesia, and 25 minutes after the end of procedure and the cortisol levels compared to standard observational measures.
Outcome: The results will inform future research into the suitability of this method and give an indication of whether cortisol saliva testing is likely to be a valuable tool for future development and usage.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0037
Date of REC Opinion
24 Feb 2015
REC opinion
Unfavourable Opinion