Research abstract
British Dental Journal 197, 553 - 558 (2004)
Published online: 13 November 2004 | doi:10.1038/sj.bdj.4811808
An RCT pilot study to test the effects of intravenous midazolam as a conscious sedation technique for anxious children requiring dental treatment — an alternative to general anaesthesia
P A Averley1, I Lane2, J Sykes3, N M Girdler4, N Steen5 & S Bond6
- Intravenous sedation in combination with inhaled nitrous oxide or inhaled nitrous oxide and sevoflurane provides a safe alternative to general anaesthesia in anxious paediatric dental patients.
- With the appropriate staff, training and facilities, these conscious sedation techniques may be safely used in a 'non hospital setting' without the risk of 'deep sedation' or anaesthesia.
- It is essential that future research in the field of paediatric conscious sedation be carried out in the United Kingdom.
Abstract
Aim To add to the evidence base for acceptable and effective paediatric conscious sedation techniques in dental primary care.
Objectives To compare three conscious sedation techniques for primary care as an alternative to dental general anaesthesia (DGA) in children. To assess the feasibility and practicality of running the trial in general dental practice. To form the basis for sample size calculations and assess scales of measurement.
Design Single centre, randomised control trial (RCT).
Setting Queensway Anxiety Management Clinic (QAMC). A primary care based general and referral dental practice for the management of anxious patients.
Subjects, materials and methods Sixty five children too anxious for management with relative analgesia, requiring invasive dental procedure for which dental general anaesthesia (DGA) will be required if an alternative cannot be found.
Interventions Group 1 (n = 20) — A combination of inhaled medical air and titrated intravenous midazolam. Group 2 (n = 22) — A combination of inhaled 40% nitrous oxide in oxygen and titrated intravenous midazolam. Group 3 (n = 23) — A combination of an inhaled mixture of 0.3% sevoflurane and 40% nitrous oxide in oxygen with titrated intravenous midazolam.
Main outcome measures Successful completion of the intended dental treatment with a child who is co-operative and responsive to verbal commands.
Results Fifty per cent (ten children) successfully completed treatment in Group 1, 73% (16 children) in Group 2 and 83% (19 children) in Group 3. This difference was not significant at a 5% level (
2 = 5.53, df = 2, P = 0.07) Of the total of 20 failures, eight children in Group 1 and one child in Group 2 were successfully treated with the addition of sevoflurane and nitrous oxide in oxygen. Only two children required referral to a hospital setting for DGA and the remaining nine children were managed with an alternative conscious sedation technique.
Conclusion This pilot shows that intravenous midazolam especially in combination with the addition of inhaled nitrous oxide or sevoflurane and nitrous oxide were promising safe and effective techniques, sufficient to justify progression to a definitive RCT with appropriate methods.
- Principal Dentist, Principal Investigator, Queensway Anxiety Management Clinic, 170 Queensway, Billingham
- Participating Dentist, Queensway Anxiety Management Clinic, 170 Queensway, Billingham
- Participating Dentist, Queensway Anxiety Management Clinic, 170 Queensway, Billingham
- Consultant/Senior Lecturer, Sedation Department, School of Dental Science, University of Newcastle upon Tyne
- Statistician, Centre for Health Service Research, University of Newcastle upon Tyne
- Head, School of Population and Health Sciences, University of Newcastle upon Tyne
Correspondence to: P A Averley1
170 Queensway, Billingham TS23 2NT
e-mail: Paul@averley.com