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Brief Summary

GUIDELINE TITLE

Safe sedation of children undergoing diagnostic and therapeutic procedures. A national clinical guideline.

BIBLIOGRAPHIC SOURCE(S)

  • Scottish Intercollegiate Guidelines Network (SIGN). Safe sedation of children undergoing diagnostic and therapeutic procedures. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2004 May. 34 p. (SIGN publication; no. 58). [130 references]

GUIDELINE STATUS

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory information has been released.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document.

The grades of recommendations (A-D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.

Preparation for Sedation

C: Parental involvement in the preparation of the child and during the procedure has a sedative-sparing effect and may greatly reduce the distress caused by separation anxiety.

D: Sedation in children should only be performed in an environment where the facilities, personnel, and equipment to manage paediatric emergency situations are immediately available.

D: Facilities undertaking paediatric sedation should possess:

  • Oxygen (a reliable source to deliver face-mask or nasal oxygen and a self-inflating positive pressure oxygen delivery system that delivers at least 90% oxygen at 15 liters/minute for at least 60 minutes with age-appropriate equipment)
  • Suction equipment
  • Tipping trolley or bed, or chair in dentistry
  • Resuscitation bags and masks of appropriate sizes
  • Oral, nasopharyngeal, and laryngeal mask, airways and endotracheal tubes of appropriate sizes
  • Pulse oximeter (with size-appropriate pulse oximeter probes)
  • Electrocardiogram (ECG) machine
  • Non-invasive blood pressure (NIBP) monitor with appropriate range of cuff sizes
  • Fully stocked emergency trolley including resuscitation drugs and specific reversal agents for benzodiazepines (i.e., flumazenil) and opioids (i.e., naloxone)
  • Defibrillator with appropriate paediatric equipment and paddles
  • Temperature monitoring for younger children undergoing long procedures
  • Capnograph to monitor expired carbon dioxide (CO2) levels is useful but not compulsory.

D: The roles and responsibilities of the "operator" (the person carrying out the procedure) and the sedation practitioner may be merged to some extent, but the guiding principle should always be that the operator should not be the person responsible for monitoring the child during the procedure.

D: In dentistry, when nitrous oxide is administered as the sole sedative agent, the operator is also usually the sedation practitioner, and, in these circumstances, should be assisted by a trained member of staff who acts as the sedation monitor. This person should have specific assignments in the event of an emergency and current knowledge of the emergency trolley inventory and basic life support.

D: Children requiring sedation should receive a full pre-procedure clinical assessment in order to classify them according to American Society of Anaesthesiologists (ASA) criteria and to ensure there are no contraindications to sedation. Only patients in American Society of Anaesthesiologists Classes I and II should be considered suitable for sedation as outpatients.

D: Children with any of the following contraindications should not normally be sedated:

  • Abnormal airway(including large tonsils and anatomical abnormalities of upper or lower airway)
  • Raised intracranial pressure
  • Depressed conscious level
  • History of sleep apnoea
  • Respiratory failure
  • Cardiac failure
  • Neuromuscular disease
  • Bowel obstruction
  • Active respiratory tract infection
  • Known allergy to sedative drug/previous adverse reaction
  • Child too distressed despite adequate preparation
  • Older child with severe behavioural problems (as they have a higher failure rate)
  • Informed refusal by the parent/guardian/child

D: Children who have any of the following additional contraindications should not be sedated with nitrous oxide:

  • Intracranial air (e.g., after skull fracture)
  • Pneumothorax, pneumopericardium
  • Bowel obstruction
  • Pneumoperitoneum
  • Pulmonary cysts or bullae
  • Lobar emphysema
  • Severe pulmonary hypertension
  • Nasal blockage (adenoid hypertrophy, common cold)
  • Pregnancy

D: Extra caution should be exercised when sedating children who have any of the following conditions (consideration should also be given to the use of a general anaesthetic or anaesthetist-supervised sedation as an alternative):

  • Neonates, especially if premature or ex-premature (these infants are particularly sensitive to the sedative and respiratory depressant effects of sedative agents)
  • Infants age <1 year and children aged <5 years (there is a higher risk of complications in these age groups due to oversedation, undersedation, and disinhibition)
  • Children with cardiovascular instability or impaired cardiac function
  • Renal impairment (this affects the pharmacokinetics of sedative agents with reduced clearance of native drug and active metabolites leading to prolonged duration, late re-sedation and sedation drift)
  • Hepatic impairment (may affect the metabolism of sedative agents resulting in prolonged duration of action; some sedative agents may precipitate hepatic encephalopathy)
  • Anticonvulsant therapy (sedative agents may act synergistically with anticonvulsant drugs to produce profound sedation; alternatively, some children are resistant to conventional doses of sedative drugs due to hepatic enzyme induction)
  • Severe respiratory disease
  • Gastro-oesophageal reflux
  • Impaired bulbar reflexes
  • Emergency cases
  • Children receiving opioids or other sedatives
  • Children receiving drugs which potentiate the action of sedatives (e.g., macrolide antibiotics potentiate and prolong the sedative effects of midazolam)

D: The classic "tell-show-do" method and other behavioural techniques should be utilised to help reduce anxiety prior to procedures.

D: The child should fast as for a general anaesthetic (6 hours for solids or bottle milk, 4 hours for breast milk, 2 hours for clear fluids), except if nitrous oxide is the only sedative used.

C: Observations from all children undergoing sedation should be recorded as a time-based record using a standardised template. All recordings, prescriptions, and reactions should be documented on this chart.

Sedation Techniques

D: Sedative drug combinations should be avoided in children as they are often associated with deeper levels of sedation and with more adverse effects.

D: The sedation practitioner must be able to manage and recover a patient who enters a deeper level of sedation than intended.

D: If a child becomes disinhibited by sedative agents and becomes restless, uncooperative, or unmanageable, elective or urgent procedures should be abandoned and re-scheduling for general anaesthesia considered. For emergency procedures, arrangements to convert to a general anaesthetic should be considered when appropriate.

C: A general anaesthetic should be considered, particularly in young children, in the medically compromised patient, for prolonged procedures, and where procedures may be painful or distressing. However, a general anaesthetic should not be performed in the general dental practice.

D: Non-pharmacological techniques should be used for painless procedures whenever possible.

C: Nurse specialist paediatric sedation services may be appropriate for some specialist children's hospitals.

D: Inhaled nitrous oxide produces the most rapid onset and offset of analgesia and may be appropriate for painful procedures in children who are able to cooperate.

C: For painful procedures requiring systemic opioid analgesia, this should be administered first and its sedative effects assessed carefully before considering adding a second sedative agent.

Specialty Requirements: Medical Paediatrics

D: For brief, but painful or distressing oncology procedures, a combination of behavioural techniques and local anaesthesia is recommended.

C: In those children where behavioural techniques are insufficient, conscious sedation and analgesia with nitrous oxide or opioids should be considered.

C: For distressing, repeated, or prolonged oncology procedures, a general anaesthetic is recommended, particularly in younger children.

D: For non-painful cardiology procedures, behavioural methods, sleep deprivation, and scheduling post-feeding may be sufficient for many children.

D: General anaesthesia is recommended for cardiac catheterisation procedures in children.

D: Renal biopsy should be carried out under general anaesthesia or with an anaesthetist administering the sedation and monitoring the child.

Specialty Requirements: Dentistry

D: Attempts should be made to persuade the child to have dental treatment under local anaesthesia using the "tell-show-do" technique, positive reinforcement, and other acclimatisation methods before dental sedation is contemplated.

C: Nitrous oxide/oxygen sedation (inhalation sedation), titrated to the individual child's needs, is recommended for use in all dental settings but particularly General Dental Practice and the Community Dental Service.

D: Dental surgeries where nitrous oxide/oxygen sedation takes place should be fitted with an up-to-date scavenging system.

D: Children undergoing inhalation sedation in a dental surgery should be monitored visually by an appropriately trained member of staff until fully recovered.

D: Single agent sedation with midazolam is only recommended for intravenous dental sedation in patients over 16 years of age. Intravenous sedation should be avoided in younger children in primary or community dental practice.

D: General anaesthetic drugs, combinations of sedative drugs, or other routes of administration should only be used in a hospital setting.

Specialty Requirements: Radiology

D: Children up to the age of 4 months should be imaged when asleep, post-feeding, and with no sedation.

C: For painless imaging procedures lasting less than 60 minutes, children from 4 months to 5 years of age may be sedated using a single low-potency oral agent.

D: As failure of sedation is often due to only part of the dose being swallowed, the drug should be given in the radiology department by the sedation practitioner. Administration from a syringe is more successful than by spoon. The bitter taste of some agents should be partially disguised in a small volume of sweet juice.

D: Interventional procedures under radiological control should be performed under general anaesthesia with topical and infiltration local anaesthesia for puncture sites.

C: Oral benzodiazepines may be used to allay anxiety in individual children for distressing procedures.

Specialty Requirements: Accident & Emergency

D: For severe pain, opioids should be used by oral, intravenous, or nasal routes, for sedating children in the accident and emergency (A&E) setting.

Definitions:

Grades of Recommendations

A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++, and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results.

B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D: Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++: High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies (e.g., case reports, case series)

4: Expert opinion

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Scottish Intercollegiate Guidelines Network (SIGN). Safe sedation of children undergoing diagnostic and therapeutic procedures. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2004 May. 34 p. (SIGN publication; no. 58). [130 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2002 Feb (revised 2004 May)

GUIDELINE DEVELOPER(S)

Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

Scottish Executive Health Department

GUIDELINE COMMITTEE

Not stated

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Guideline Development Group: Dr Neil Morton, (Chairman), Consultant in Paediatric Anaesthesia, Department of Anaesthetics, Royal Hospital for Sick Children, Glasgow; Ms Susan Aitkenhead, Paediatric Pain Control Nurse Specialist, Royal Hospital for Sick Children, Glasgow; Dr Tom Beattie, Consultant Paediatrician, Paediatric A&E Medicine, Royal Hospital for Sick Children, Edinburgh; Mrs Margaret Dolan, Chief Pharmacist, St John's Hospital at Howden, Livingston; Dr Ali El-Ghorr, Programme Manager, Scottish Intercollegiate Guidelines Network; Mr Robin Harbour, Information Manager, Scottish Intercollegiate Guidelines Network; Miss Diane Fung, Consultant in Paediatric Dentistry, Glasgow Dental Hospital & School NHS Trust, Glasgow; Dr Stephanie Mackenzie, Consultant Paediatric Radiologist, Royal Hospital for Sick Children, Edinburgh; Dr Jack McDonald, Consultant Paediatrician, Raigmore Hospital, Inverness; Dr Donald Miller, Consultant Anaesthetist, Glasgow; Dr James Paton, Reader and Hon Consultant Paediatrician, Royal Hospital for Sick Children, Glasgow; Ms Clare Taylor, Patient Representative, former Greater Glasgow Health Council (1994-2001); Dr Mike Wilson, General Practitioner, Dalkeith; Professor George Youngson, Paediatric Surgeon, Royal Aberdeen Children's Hospital, Aberdeen

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

All members of the Scottish Intercollegiate Guidelines Network (SIGN) guideline development groups are required to complete a declaration of interests, both personal and non-personal. A personal interest involves payment to the individual concerned, e.g., consultancies or other fee-paid work commissioned by or shareholdings in the pharmaceutical industry; a non-personal interest involves payment which benefits any group, unit or department for which the individual is responsible, e.g., endowed fellowships or other pharmaceutical industry support. SIGN guideline group members should be able to act as independently of external commercial influences as possible, therefore, individuals who declare considerable personal interests may be asked to withdraw from the group. Details of the declarations of interest of any guideline development group member(s) are available from the SIGN executive.

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on September 30, 2002. The information was verified by the guideline developer on October 28, 2002. This NGC summary was updated by ECRI on October 13, 2004. The information was verified by the guideline developer on January 26, 2005. This summary was updated by ECRI Institute on April 30, 2007, following the FDA advisory on Sedative-hypnotic drug products.

COPYRIGHT STATEMENT

DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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