Review Protocol – Midazolam (safety)

Review questionFor children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is midazolam (with or without: analgesia, another drug or psychological techniques) safe for sedation (at mild, moderate, and deep levels) in different settings?
ObjectivesTo estimate the safety of midazolam.
Infants, children and young people (under 19 years) receiving sedation by any technique for painful or non-painful diagnostic or therapeutic procedures including dental surgery and minor operations carried out under local anaesthesia.
InterventionSedation for diagnostic or therapeutic procedures.
ComparisonThe following comparisons will be included.
  • intervention (including combinations) versus no intervention or placebo or usual care
  • intervention A versus B
  • intervention A + B versus B
  • pharmacological versus non-pharmacological
  • pharmacological + non-pharmacological versus non-pharmacological
  • pharmacological + analgesia versus analgesia
  • pharmacological versus general anaesthesia
  • dose A versus dose B
  • duration 1 versus duration 2
  • route of administration 1 versus 2
OutcomesOutcomes for safety of midazolam::
  • Aspiration
  • Respiratory intervention, including:
    • oral-pharyngeal airway
    • endotracheal intubation
    • assisted ventilation
  • Cardiac arrest requiring either/or:
    • external cardiac massage
    • defibrillation
  • Oxygen desaturation <90%
  • Vomiting
Search strategyThe databases searched were Medline (from 1950 to Jan 18th 2010), Embase (from 1980 to Jan 18th 2010), The Cochrane Library (all dates available to 2009 Issue 4) and CINAHL (from 1982 to Jan 18th 2010).

Studies were restricted to English language only.

Searches were not restricted by study design.
The review strategyThe review for drug safety will be based upon both RCT and non-RCT observational evidence. For RCT evidence, study details, methodology and results will be extracted into an Access database. Further statistical analysis and meta analysis will be conducted where possible and carried out in Rev Man as required. For non-RCT observational evidence, study details and results will be extracted into tables and rates of adverse events will be calculated as required. All evidence will be reviewed by the GDG. An evidence profile and quality assessment will be then entered into GRADE. The methods of reviewing are detailed in Chapter 2.

From: Appendix H, Review protocol form

Cover of Sedation in Children and Young People
Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet].
NICE Clinical Guidelines, No. 112.
National Clinical Guideline Centre (UK).
Copyright © 2010, National Clinical Guideline Centre.

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