Sedation of patient receiving intensive care
▶INITIALLY BY SLOW INTRAVENOUS INJECTION
▶Child 6 months–11 years:Initially
50 – 200 micrograms/kg, to be administered over at
least 3 minutes, followed by (by continuous
intravenous infusion) 30 – 120 micrograms/kg/hour,
adjusted according to response, initial dose may not be
required and lower maintenance doses needed if opioid
analgesics also used; reduce dose (or reduce or omit
initial dose) in hypovolaemia, vasoconstriction, or
hypothermia
▶Child 12–17 years:Initially 30 – 300 micrograms/kg, dose
to be given in steps of 1 – 2. 5 mg every 2 minutes,
followed by (by continuous intravenous infusion)
30 – 200 micrograms/kg/hour, adjusted according to
response, initial dose may not be required and lower
maintenance doses needed if opioid analgesics also
used; reduce dose (or reduce or omit initial dose) in
hypovolaemia, vasoconstriction, or hypothermia
▶BY CONTINUOUS INTRAVENOUS INFUSION
▶Neonate up to 32 weeks corrected gestational
age: 60 micrograms/kg/hour for 24 hours, then reduced
to 30 micrograms/kg/hour, adjusted according to
response for maximum treatment duration of 4 days.▶Neonate 32 weeks corrected gestational age and
above: 60 micrograms/kg/hour, adjusted according to
response for maximum treatment duration of 4 days.▶Child 1–5 months: 60 micrograms/kg/hour, adjusted
according to responselUNLICENSED USEOromucosal solution not licensed for use
in children under 3 months. Unlicensed oromucosal
formulations are also available and may have different
doses—refer to product literature. Injection not licensed
for use in status epilepticus or febrile convulsions. Not
licensed for use in children under 6 months for
premedication and conscious sedation. Not licensed for
use by mouth. Not licensed for use by buccal
administration for conscious sedation.IMPORTANT SAFETY INFORMATION
ANAESTHESIA
Benzodiazepines should only be administered for
anaesthesia by, or under the direct supervision of,
personnel experienced in their use, with adequate
training in anaesthesia and airway management.lCONTRA-INDICATIONSCNS depression.compromised
airway.severe respiratory depression
lCAUTIONSCardiac disease.children (particularly if
cardiovascular impairment).concentration of midazolam
in children under 15 kg not to exceed 1 mg/mL.debilitated
patients (reduce dose).hypothermia.hypovolaemia (risk
of severe hypotension).neonates.risk of airways
obstruction and hypoventilation in children under
6 months (monitor respiratory rate and oxygen saturation)
.vasoconstriction
CAUTIONS, FURTHER INFORMATION
▶Recovery when used for sedationMidazolam has a fast onset
of action, recovery is faster than for other benzodiazepines
such as diazepam, but may be significantly longer in
patients with a low cardiac output, or after repeated
dosing.
lINTERACTIONS→Appendix 1 : midazolam
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonLevel of consciousness decreased
.vomiting
▶UncommonSkin reactions▶Rare or very rareApnoea.bradycardia.cardiac arrest.
constipation.dry mouth.dyspnoea.euphoric mood.
hiccups.hostility.movement disorders.physical assault.
respiratory disorders.vasodilation
▶Frequency not knownAppetite increased.disinhibition
(severe; with sedative and peri-operative use).embolism
and thrombosis.fall.saliva altered
SPECIFIC SIDE-EFFECTS
▶With parenteral useAngioedema.drug abuse.drug
tolerance.drug withdrawal seizure
SIDE-EFFECTS, FURTHER INFORMATIONHigher doses are
associated with prolonged sedation and risk of
hypoventilation. The co-administration of midazolam with
other sedative, hypnotic, or CNS-depressant drugs results
in increased sedation. Midazolam accumulates in adipose
tissue, which can significantly prolong sedation, especially
in patients with obesity, hepatic impairment or renal
impairment.
OverdoseThere have been reports of overdosage when
high strength midazolam has been used for conscious
sedation. The use of high-strength midazolam ( 5 mg/mL in
2 mL and 10 mL ampoules, or 2 mg/mL in 5 mL ampoules)
should be restricted to general anaesthesia, intensive care,
palliative care, or other situations where the risk has been
assessed. It is advised thatflumazenil is available when
midazolam is used, to reverse the effects if necessary.
lBREAST FEEDINGSmall amount present in milk—avoid
breast-feeding for 24 hours after administration (although
amount probably too small to be harmful after single
doses).
lHEPATIC IMPAIRMENTUse with caution particularly in
sedative doses; can precipitate coma. For status
epilepticus and febrile convulsions: use with caution in
mild to moderate impairment; avoid in severe impairment.
lRENAL IMPAIRMENTUse with caution in chronic renal
failure.
lDIRECTIONS FOR ADMINISTRATION
▶With intravenous useForintravenous infusion(Hypnovel®),
give continuouslyinGlucose 5 %orSodium chloride 0. 9 %.
Forintravenous injectionin status epilepticus and febrile
convulsions, dilute with Glucose 5 % or Sodium Chloride
0. 9 %; rapid intravenous injection (less than 2 minutes)
may cause seizure-like myoclonus in preterm neonate. For
neonate and children under 15 kg dilute to a max.
concentration of 1 mg/mL.Neonatal intensive care, dilute
15 mg/kg body-weight to afinal volume of 50 mL with
infusionfluid; an intravenous infusion rate of 0. 1 mL/hour
provides a dose of 30 micrograms/kg/hour.
▶With oral useFor administrationby mouthfor sedation and
premedication, injection solution may be diluted with
apple or black currant juice, chocolate sauce, or cola.
lPRESCRIBING AND DISPENSING INFORMATIONThe RCPCH
and NPPG recommend that, when a liquid special of
midazolam is required, the following strength is used:
10 mg/ 5 mL.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer midazolam oromucosal
solution.
Patients given sedatives and analgesics during minor
outpatient procedures should be very carefully warned
about the risks of undertaking skilled tasks (e.g. driving)
afterwards. For intravenous benzodiazepines the risk
extends toat least 24 hoursafter administration.
Responsible persons should be available to take patients
home afterwards. The dangers of takingalcoholshould be
emphasised.
Medicines for Children leaflet: Midazolam for stopping seizures
http://www.medicinesforchildren.org.uk/midazolam-for-stopping-
seizures224 Epilepsy and other seizure disorders BNFC 2018 – 2019
Nervous system4