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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.
Br Dent J. 2004 Nov 13; 197(9):553-8; discussion 549.BD

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 (chi(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.

Authors+Show Affiliations

Principal Dentist, Principal Investigator, Queensway Anxiety Management Clinic, 170 Queensway, Billingham. paul@averly.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15543117

Citation

Averley, P A., et al. "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." British Dental Journal, vol. 197, no. 9, 2004, pp. 553-8; discussion 549.
Averley PA, Lane I, Sykes J, et al. 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. Br Dent J. 2004;197(9):553-8; discussion 549.
Averley, P. A., Lane, I., Sykes, J., Girdler, N. M., Steen, N., & Bond, S. (2004). 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. British Dental Journal, 197(9), 553-8; discussion 549.
Averley PA, et al. 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. Br Dent J. 2004 Nov 13;197(9):553-8; discussion 549. PubMed PMID: 15543117.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Averley,P A, AU - Lane,I, AU - Sykes,J, AU - Girdler,N M, AU - Steen,N, AU - Bond,S, PY - 2003/05/11/received PY - 2003/11/28/accepted PY - 2004/11/16/pubmed PY - 2005/1/26/medline PY - 2004/11/16/entrez SP - 553-8; discussion 549 JF - British dental journal JO - Br Dent J VL - 197 IS - 9 N2 - 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 (chi(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. SN - 0007-0610 UR - https://www.unboundmedicine.com/medline/citation/15543117/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_ L2 - https://doi.org/10.1038/sj.bdj.4811808 DB - PRIME DP - Unbound Medicine ER -