Procedural sedation guideline Aim: The aim of the Procedural Sedation Guideline is to provide medical and nursing staff outside of theatre, ICU and ED with a guide for achieving safe sedation of patients in the clinical area. This guideline outlines Procedural sedation involving single oral agent, administration of nitrous oxide and intravenous midazolam. Deep sedation should only be used in designated areas such as Theatres and ICU's; whereby the patient can remain in that location for the full duration of the sedation period under direct supervision. Key principles: The key principles of procedural sedation to consider are: Benefit risk ratio: The benefits of using procedural sedation should at all times outweigh the risks. The use of procedural sedation should be less distressing than the procedure performed without it. Define need vs. availability: Appropriately define patients whom minimal to moderate sedation is indicated for the procedure. Adequate appropriately competent/accredited staff are available to administer the sedation agent and monitor the patient Consult/ Refer/ Recruit help: Clinician's should utilise resources such as consulting a peer or expert colleague before proceeding, if they are uncertain of the appropriateness of the staff, the patient or the equipment for the proposed sedation. Additional measures for analgesia/ anxiolysis: Appropriate non pharmacological techniques such as distraction or diversion activities or involvement of an Educational Play Therapist should be an integral part of the process. Appropriate local anaesthesia or other analgesia should be used for procedures whether or not a sedation agent is used. Indications Lumbar puncture Plaster care Electrophysiological studies Wound dressing care Diagnostic radiology, Venepuncture Intercostal /drain catheter Skin biopsy Nasogastric or catheter. Pin care Procedure duration <45 minutes Exclusion Criteria: Nitrous oxide: Bowel obstruction Pneumothorax Middle ear disease Decompression sickness Use of other drugs: Allergies to specific drugs to be considered and risk of failure or increased sedation to be considered in case of >1 drug use. Intoxication Other factors for specific drugs – ketamine and head injury etc. Risk assessment criteria The purpose of the risk assessment criteria is to assist clinicians to identify conditions, disease groups or agents that may result in an adverse event such as loss of airway, drug interaction, prolonged sedation or agitation. Significant risk of airway compromise leading to obstruction – airway assessment Airway infection; increased risk of bronchospasm or laryngospasm Increased risk of hypoventilation Increased risk of aspiration Increased risk of cardiovascular compromise Immunosuppression: (nitrous oxide can interfere with Folate and B12 metabolism) Severity of illness History of sedation failure including adverse event Patients < 6 months Patient < 2 years for nitrous oxide or IV midazolam Patient assessment A thorough patient assessment should be completed prior to a sedation agent being used. This includes: AMPLE previous sedation experiences and drugs used (including if the child has had a previous reaction to standard doses of sedation drugs) physical examination including: o current weight o baseline vital signs (Heart Rate (HR), Respiratory Rate (RR), Oxygen Saturation (Spo2), NonInvasive Blood Pressure (NIBP), Glascow Coma Scale (GCS), and UMSS sedation score Preparation for administering sedation – CIF SPEND Consent Consent should be obtained prior to the procedure as per local guidelines Informed consent for the procedural sedation agent must be obtained by a staff member who has an understanding of the sedation agent and can explain to the patient/ parent/carer the indications for its use and possible risks involved. Time Out" or "Positive Patient Identification" Fasting Recommended minimum fasting times for Procedural Sedation are consistent with current clinical practice in Australian paediatric centres and College of Physician Guidelines. For ward patients and outpatients fasting times are: o Oral agents: 2 hours solids and liquids including breastfeeding o Nitrous oxide 2 hours solids and liquids including breastfeeding o IV midazolam: 6 hours solids, 4 hours breastfeed, 2 hours clear fluid NB: specialised areas such as the Emergency Department, Intensive Care Unit and Department of Anaesthesia have variation to the fasting guidelines this is based on the specific clinical environment and expertise. Environment To minimise procedural anxiety: Appropriate lighting and minimal noise. Prepare the venue and all necessary equipment (keeping needles out of sight) before the patient enters. Assess department and communicate isolation from other responsibilities until completion of procedures. Delegate responsibilities. Child and parent Optimising the parent's role reduces the child's anxiety during the procedure; staff should be sensitive to parents who are not able to provide this support. Children usually cope better with the parent(s) or guardian present, for adolescents discuss if a parent's presence is preferred. 1 Non-pharmacological techniques should be planned and employed during procedures to complement and sometimes prevent the need for sedation agent. Equipment In any circumstance where a patient may be sedated the following equipment must be available, turned on and functioning: Standard hospital resuscitation trolley with all age-appropriate equipment Functional suction apparatus with attachment. Saturation oximeter and blood pressure monitoring equipment. An emergency call system to summon additional help if required A room and appropriate size bed or trolley to monitor and recover the child appropriately. Staffing Staffing requirements are: o For oral agents: 2 staff required, 1 competent RN or medical staff member o For nitrous oxide: 2 staff required, 1 accredited to administer the agent o For IV agents: 2 staff required, 1 accredited to administer the agent Procedural sedation agents Patient's should not receive sedative drugs prior to arrival at hospital. Sedated patients should not be placed in corridor or waiting room areas. Sedation drug (s) should be documented on Medication Chart MR52. o Midazolam o Chloral Hydrate o Nitrous oxide Agent Pharmacokinetics Nitrous oxide (N2O) Onset : 20 seconds Peak effect: 3 -5 minutes. Nitrous oxide has low blood solubility thus rapid clearance with exhalation. Rapid fall in arterial concentration once inhalation stops. Low fat solubility - does not significantly accumulate within the body. Complete recovery usually in approximately 5 minutes. Midazolam Short acting Anxiolytic/sedative Central nervous system depressant No analgesic properties Oral Absorption is rapid, but erratic Max effect within 15- 60 mins Duration up to 2 hrs Nasal Administration technique is important. Common Side Effects/Adverse Reactions Dizziness or lightheadedness Mild nausea Vomiting Adverse reactions: Expansion of closed gas filed space. Respiratory depression Apnoea Pulmonary aspiration of gastric contents if protective airway reflexes impaired Folate metabolism and vitamin B12 suppression Cardiac depression Apnoea and respiratory depression "Paradoxical reaction" (agitation secondary to benzodiazepines) Emergence delirium Midazolam will potentate the effects of other sedative drugs eg. opioids. Dose Range Reversal Agents N2O delivery range: a maximum of 70% N2O and 30% O2. Maximum dose 70%, less if opioids are being used. No reversal agent. Give 100% O2, full recovery in approximately 5 minutes. Oral 0.5 mg/kg (to maximum of 15 mg) Give dose 20 -30 min prior to treatment. Nasal 0.2-0.4 mg/kg (to maximum of 10 mg) Use 5 mg/mL midazolam for injection Flumazenil Give 5mcg/ kg every 60 seconds to a maximum total of 40 mcg/ kg. Adult dose: 300-600 mcg. NOT required at time of administration, available on PICU Resuscitation Trolley. Drop dose into alternating nostrils over 15 secs. Absorption is rapid Maximal effect in 10 mins Duration up to 2 hrs May be irritating and should only be used if a rapid effect is required. Intravenous Onset of action 1-5 mins For the purpose of procedural sedation, titrate the dose until desired level of sedation achieved. Chloral Hydrate Sedative/Hypnotic Unpredictable onset Long duration Hyperactivity occurs in 1-2% of patients Liver failure (rare). Respiratory depression is less common compared with other sedatives. Intra-nasal delivery stings and should preferably not be used Intravenous 0.15mg/kg( maximum of 7.5mg) diluted in 10mls of Normal Saline Give bolus of 0.010.02 mg/kg every 2-3 minutes until adequate level of sedation is achieved DO NOT exceed maximum dose. Oral / Rectal 50 mg/kg (to maximum of 2g) as a single dose. No reversal agent. Sedation procedure Prior to the sedation Document baseline vital signs immediately prior to commencement including: o HR o RR o NIBP (for intravenous agents) o SPO2 o GCS o UMSS sedation score During sedation period Patient must remain in the Line of sight (hyperlink to definition of terms) of a competent clinician (oral agents) or accredited staff member during the procedure for nitrous oxide and IV agents. Continuous pulse oximetry is required during the procedure and if the sedation score is > 1. If sedation score is equal to > 2: Observe and record vital signs every 5 minutes. Post sedation period Place child in the "recovery" position. The 'Sedation Period" is considered over when the patient meets the following criteria: o return to baseline sedation score and vital signs are within normal limits for the patient o easily rousable and have intact protective airway reflex o can talk if developmentally appropriate NB: If the patient has not met these criteria continue to reassess and monitor the child in "recovery" lateral position and keep nil orally. Transport It is recommended that patient's who require transportation during the 'sedation period ': Are accompanied by a competent or accredited clinician Are placed in the "recovery" lateral position Require continuous oxygen saturation monitoring Require suction, oxygen and an appropriate sized bag and mask available at all times during transportation Documentation Complete "Record of Sedation for Procedures" (MR56S). Medications( including nitrous oxide) must be prescribed on the patient's Hospital Medication Chart (MR52) Docuement observations on MR 77 or MR52B. Procedure summary: a summary of the procedure including: o Procedure event with reference to the equipment, number of attempts, and procedure assessment. o Recommendations for future interventions o Parental consent for both the intervention and pharmacological agents used. Additional discharge criteria for outpatient Discharge home may be considered (provided other medical factors permit) when the patient meets the following discharge criteria: The patient can sit up unaided / walk ( developmentally appropriate) The patient has returned to pre sedation observations (both vital signs and level of sedation) A responsible adult is present to accompany the patient home (for all ages) Post sedation care has been discussed with parents/guardians. Safety and injury prevention must be highlighted. Occupational health concerns Prolonged and repetitive exposure to N2O can suppress liver enzymes involved with vitamin B12 and folate metabolism and inactivate vitamin B12. Occupational exposure can be kept to a minimum by ensuring a suitable scavenging system is used and a consistent and adequate mask seal to the patient's face is maintained. The scavenging system should be connected directly to piped wall suction only (never portable) and turned to a medium flow. Pregnancy and nitrous oxide: Exposure to nitrous oxide should be avoided during pregnancy. It is recommended that exposure to nitrous oxide not occur in the first trimester of pregnancy. Occasional brief exposure later in pregnancy is considered 'low risk' Repeated exposure should be avoided in the 2nd and 3rd trimesters.