Best clinical practice guidance for conscious

sedation of children undergoing dental

treatment: an EAPD policy document.
Ashley P, Anand P, Andersson K.
European Archives of Paediatric Dentistry.
2021 Dec;22(6):989-1002
doi.org/10.1007/s40368-021-00660-z
Houpt behavioural score
Abstract
• Background Due to fear and/or behaviour management problems, some children are unable to cooperate for dental
treatment using local anaesthesia and psychological support alone. Sedation is required for these patients in order for
dentists to be able to deliver high quality, pain-free dental care.
• The aim of this guideline is to evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for
behaviour management in paediatric dentistry and to provide guidance as to which sedative agents should be used.
• Methods These guidelines were developed using a multi-step approach adapted from that outlined by the National
Institute for Clinical Excellence (NICE (2020) Developing NICE Guidelines: the manual.
https://www.nice.org.uk/process/pmg20/ chapter/introduction# main-stages-of-guideline-development. Accessed 7
Oct 2020). Evidence for this guideline was provided from a pre-existing Cochrane review (Ashley et al. Cochrane
Database Syst Rev 12:CD003877, 2018) supplemented by an updated search and data extraction up to May 2020.
• Results Studies were from 18 different countries and had recruited 4131 participants overall with an average of 70
participants per study. Ages ranged from 0 to 16 years with an average age of 5.6 years across all included studies. A
wide variety of drugs or combinations of drugs (n=38) were used and delivered orally, intranasally, intravenously,
rectally, intramuscularly, submucosally, transmucosally or by inhalation sedation. Twenty-four different outcome
measures for behaviour were used. The wide range of drug combinations and outcome measures used greatly
complicated description and analysis of the data.
• Conclusion Oral midazolam is recommended for conscious dental sedation. Midazolam delivered via other methods or
nitrous oxide/oxygen sedation could be considered, but the evidence for both was very low.
INTRODUCTION

• There are two main dimensions to paediatric oral care

• Maintenance of good oral health will often require operative intervention.

• Treatment can be performed with delivery of general anaesthesia

-Ashley et al. 2018

• Sedation is an alternative for these child patients

• Objectives for sedation in paediatric dentistry

The child

• Reduce fear and perception of pain during the treatment

• Facilitate coping with the treatment

• Prevent development of dental fear and anxiety

The dentist

• Facilitate accomplishment of dental procedures

• Reduce stress and unpleasant emotions

Conscious sedation can be defined as

• Minimally depressed consciousness

• Ability to maintain open airway

• Protective reflexes maintained

• Response to verbal and physical stimulation

Aim

• To evaluate the efficacy and relative efficacy of conscious sedation agents and

dosages for behaviour management in paediatric dentistry

• To provide guidance as to which sedative agents should be used.

• In addition, this guideline will provide a clinical protocol to guide dentists on the

use of recommended dental sedative agents

Methodology

• These guidelines were developed using a multi-step approach adapted from the
National Institute for Clinical Excellence (NICE 2020).

Studies were selected if they met the following criteria:

• Randomised controlled trials of conscious sedation comparing two or more

drugs/techniques/placebo undertaken by the dentist or one of the dental team in
children up to 16 years of age.

• Quasi-randomised trials and cross-over trials were excluded.

• Searches were carried out by the Cochrane Oral Health Information Specialist in

the following databases till 20 May 2020.

• Cochrane Oral Health Trials Register

• Cochrane Central Register of Controlled Trials

• Medline OVID

• Embase OVID

• Risk of Bias was assessed using Cochrane’s risk of bias tool

Data synthesis

Outcomes considered were

• Completion of treatment (yes/no)

• Difference in behaviour between test and control groups

• Difference in post-operative anxiety between test and control groups

• Adverse events
• The certainty of the evidence was assessed using GRADE methodology.

• Outcomes: mean Houpt/other behavioral score and good or better behaviour,

and adverse events.

• Certainty of each body of evidence as high, moderate, low, or very low.

• Economic factors were not considered.

Studies were separated into three categories:

• Studies where test drug(s) were compared to a placebo.

• Studies where differing dosages of the same drug(s) were compared.

• Studies comparing different drugs or combinations of drugs.

Adverse effects

• Chloral hydrate- airway issues - >50 mg/kg were combined with the use of

inhalational nitrous oxide.

• Ketamine was also associated with significant adverse effects

• Diazepam was not recommended as an agent for the dental sedation of children

• Preoperative anxiolysis the day before surgery

Clinical Protocol - Midazolam and Nitrous oxide

Patient selection and assessment

• Patient assessment

• ASA Class I or Class II - conscious sedation - outpatients.

• ASA Class III and Class IV - individual consideration - hospital environment.

Indications

1. Children unable to cope

2. Treatment required

Contraindications

Sedation of children below the age of 1 year or 10 kgs – should not be performed

without consulting anaesthesiologist

Patient information

• Written and oral information and consent

Patient monitoring
• Clinical monitoring

• The clinical team must be able to recognise a deteriorating patient and manage
accordingly.

• Any electronic monitoring used must be age appropriate.

Pulse oximetry and blood pressure monitoring
• In conscious sedation, oxygen desaturation below 95% in children is rare.

• Pulse oximetry and blood pressure monitoring is not usually deemed necessary
for conscious sedation with nitrous oxide/oxygen but is normally expected for
benzodiazepine sedation.

• When pulse oximetry is used, the alarms may show false positive

• Young children especially may react with increased anxiety to the placement of
the pulse oximeter.
Fasting
• Fasting prior to sedation continues to be a controversial

• There is only low evidence available for this

• If the decision is to not fast- avoid alcoholic drinks and large meals.

• If there is a significant risk of aspiration, or another indication, consider fasting

prior to sedation.

• The 2–4–6 fasting rule is recommended in this situation.

• It is advisable to confirm and record food and fluid intake on the day of sedation.
Discharge

• The recovery of a child must be assessed before discharge.

• In case of midazolam sedation, adult should ensure that the child is in a position

to facilitate breathing.
Documentation and records
• Medical history including prescribed medication
• Previous dental history
• History of previous conscious sedations and general anaesthesia
• Indication for the use of conscious sedation
• Pre-sedation assessment
• Written instructions provided pre- and post-operatively
• Presence of an accompanying responsible adult
• Compliance with pre-treatment instructions
• The course of the treatment
• Monitoring – Dose, and route of administration, Sedation evaluation (sedation
scale) , Acceptance of sedation and treatment (behavioural scale)
• Complications ,post-sedation assessment and time of discharge
Nitrous oxide

• GABA a and NMDA- receptors are affected by nitrous oxide

-Sanders et al. 2008

• Nitrous oxide must be given in a mixture with oxygen (>30%).

• Nitrous oxide is non-irritant to the respiratory tract

• Nitrous oxide has an onset and recovery within minutes

Indications

• Cope with nasal breathing instructions, often 3 years and older.

• Strong gag reflex

• Muscular tone disorders

• ASA Class III and Class IV but treatment of these patients should be in conjunction

with responsible medical colleagues and in a hospital setting.

Contraindications
• Pre-co-operative children

• Patients with upper airway problems

• Middle ear infection

• Patients with sinusitis or recent ENT operations (within 14 days)

• Patients in bleomycin chemotherapy

• Severe emotional or drug-related dependencies

• Chronic obstructive pulmonary disease

• Raised intraocular pressure, retinal surgery, intestinal obstructive surgery

• Untreated B12 deficiency

Adverse effects

• Over sedation

• Nausea, vomiting,

• Sweating, dysphoria, restlessness, panics and headache

Technique

• Sedation is initiated by inhalation of pure oxygen for 2–5 min.

• The maximum recommended concentration of nitrous oxide varies from 50 to 70%.

• The commonly effective dosage for most children tends to be 30–40%.

Potential interactions

• Nitrous oxide may amplify the effects of other sedatives, e.g., opioids,

benzodiazepines, leading to CNS depression.

• There are no known potential interactions with other drugs.

Safety for the staff
• Chronic exposure to certain environmental concentrations of nitrous oxide -
health risk for the dental staff

-Zafna et al. 2019

• Efficient scavenging system

• Appropriate technique for disconnection of the delivery system

• Methods for testing the integrity of the breathing system.

 Midazolam

• Rapid onset of action.

• benzodiazepine receptor in the CNS - enhances the inhibitory action of the

neurotransmitter GABA.

• Increasing the flux of chloride ions through the ion channels of the nerve cell.

• Ability to initiate an action potential

-Nordt and Clark

Contraindications
• Children under the age of 1 year or body weight<10 kg
• Children with any form of acute disease
• Children with respiratory or cardiac disease that affects daily life
• Children with neuromuscular diseases
• Children with allergy to BZD
• Children with sleep apnoea
• Children with liver, hepatic dysfunction (dose adjustment may be necessary)
• Children with porphyria
Adverse effects
• Hiccups

• Nausea

• Respiratory depression

• Interactions with other medication

• Paradoxical reaction

• Over sedation

• Hallucination
Clinical considerations

• All drugs in use in the treatment area must be clearly labelled and each drug

should be given according to accepted recommendations.

• Flumazenil should be available

Routes
• Oral midazolam

• A preformulated flavoured syrup is also available for use.

• IV midazolam - a cannula directly into circulation

• Transmucosal administration (rectal and intranasal) - advantage of depositing the

drug directly into the systemic circulation.

• Rectal administration requires syringes and a rectal applicator.

• Intranasal sedation can be sprayed into one nostril.

Dosage
Oral

• Children under 25 kg - 0.3–0.5 mg/kg bodyweight.

• Maximum dose: 10–12 mg based on local legislation.

• Children over 25 kg - 10–12 mg midazolam based on local legislation.

Rectal

• Children under 25 kg - 0.3– 0.4 mg/kg bodyweight.

• Maximum dose 10 mg midazolam.

• Children over 25 kg - 10 mg
Intranasal

Intranasal sedation - one nostril- Mucosal atomizer device (MAD).

Dosage 0.2 mg/kg, maximum dose 10 mg.

Intravenous

1 mg initial loading dose over 60 s followed by 60 s increment of 1 mg until patient

is ready for treatment.

Dosage - 2 to 7.5 mg

The effect of sedation may exhibit an interpersonal and intrapersonal variation.

Potential interactions

• Intake of erythromycin, hypnotics, anxiolytics, antidepressants, some antifungals,

some antivirals, antipsychotics, antiepileptics, antihistamines, opioids, grapefruit

juice, clonidine and alcohol can enhance the effect.

Flumazenil–midazolam antidote
• Antidote to benzodiazepines through competitive inhibition.

• Elimination half-time of Flumazenil -shorter than that of midazolam.

• Repeat doses of flumazenil may be required for this reason

• Child>1 yr - 10 µgm/kg, up to 200 µgm - over 15 s

• Repeat every 1 min×4, max 1 mg, i.e., two ampules of 500 µgm or 50 µgm/kg,
whichever is less

• 5 yrs - 20 kg child- max 1000 µgm (2 amps)

• 12 yrs - 40 kg child - max 1000 µgm (2 amps)

Mandatory equipment for emergency situations during sedation with midazolam

• Oxygen equipment

• Ventilation mask

• Pulse oximeter
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