A BBC article reported that dentists had developed an alternative to general anesthesia for children who need to be sedated for complex dental work.
Where does the evidence come from?
The study was conducted by researchers at the University of Newcastle upon Tyne and is published in the journal Anaesthesia:
Averley PA, Girdle NM, Bond S, Steen N, Steel J. A randomsied controlled trial of paediatricx conscious sedation for dental treatment using intravenous midazolam combined with inhaled nittrous oxide or nitrous oxide/sevoflurane. Anesthesia. 2004; 59: 844-852.
What were the objectives of the study?
To establish whether the use of a combination of intravenous (IV)midazolam with inhalation agents (nitrous oxide alone or in combination with sevoflurane) was any more likely to result in successful completion of treatment than midazolam alone.
A further aim was to evaluate the clinical viability of these techniques as an alternative to general anesthesia.
What was the nature of the evidence?
The study was a large randomised controlled trial of children too anxious for management with relative analgesia and requiring ivasive dental procedure. 848 children were randomised to the groups below, but only 697 children received the intervention:
• Group 1 (n= 222) - Inhaled medical air + titrated IV midazolam
• Group 2 (n=308) - Inhaled 40% nitrous oxide in oxygen + titrated IV midazolam
• Group 3 (n= 320) - Inhaled mixture of sevoflurane 0.3% and nitrous oxide 40% in oxide with titrated IV midazolam.
The numbers of children recruited into Group 1 are lower than the other Groups. This was because an interim analysis conducted by a committee independent from the research team found that Group 1 had a high failure rate. This arm of the study was therefore discontinued and the trial proceeded with only Group 2 or 3.
The main outcome measure was successful completion of the treatment with a co-operative child responsive to verbal commands which was assessed by the dentist. The dentist was blind to the gases administed by anaesthetist.
What were the findings?
In group 1, 54% (94/174 children) successfully completed treatment.
In group 2, 80% (204/256) and in group 3, 93% (249/267 children) completed treatment. This difference was significant at the 1% level.
What were the authors' conclusions?
The authors conclude intravenous midazolam, especially in combination with inhaled nitrous oxide or sevoflurane and nitrous oxide, are effective techniques, with the combination of midazolam and sevoflurane the one most likely to result in successful treatment.
How reliable are the conclusions?
This is a large generally well conducted UK study. However, whilst 848 children were randomised to the three groups, 16% (151 children) did not receive the intervention. An intention to treat analysis was performed on all those who accepted the nose mask (697 children).
How did the media report the studies findings?
The news item closely reported the results for Group 3, but did not report the results found for Group 1 and 2. Comments are also provided from the authors, the British Dental Assocation, the Chief Dental Officer for Wales, and the family of one of the children receiving the intervention.
Links to the relevant, available news articles
BBCi News. Alternative for Dental Sedation. 1 September 2004
