Procedural Sedation and Analgesia (2024)

by Nik Hisamuddin Nik Ab Rahman

Introduction

Sedation for painful procedures involves the administration of drugs by any route or technique that results in a reduction of awareness and pain levels. The main aim of procedural sedation analgesia (PSA) is to reduce discomfort while maintaining the effective performance of the procedure. Effective PSA induces a reduced level of consciousness while enabling the patient to independently sustain oxygenation and manage their airway [1, 2].

The use of sedation involves certain risks, including:

Impairment of the patient’s protective reflexes, which can result in airway obstruction or aspiration.
Suppression of respiratory and cardiovascular functions, which may lead to complications such as hypoxia, hypotension, bradycardia, or even cardiac arrest.

The effects of sedative medications can vary, with the possibility of over-sedation or airway obstruction at any point. Ensuring patient cooperation and maintaining verbal communication are critical objectives for procedural sedation. These guidelines are designed to assist non-anaesthesiologists in safely administering sedation and analgesia to adult patients, whether in an operating room or other settings, to minimize risks and enhance patient safety [3].

When sedation is managed by non-anaesthesiologists, it is essential to limit the sedation level to minimal or moderate. The ideal goal is to achieve a moderate level of consciousness, allowing the patient to independently maintain their airway and cardiovascular stability. Deep sedation should be avoided unless an emergency physician skilled in airway management or an anaesthesiologist is present throughout the procedure (Figure 1).

Goals of PSA include:

Ensuring patient safety before, during, and after PSA.
Minimizing pain and anxiety associated with the procedure.
Reducing the patient’s movement during the procedure.
Maximizing the likelihood of procedural success and facilitating the patient’s return to their pre-sedation state as quickly as possible.

Indications

Alleviate pain and/or anxiety commonly associated with therapeutic or diagnostic procedures.
Enhance the success of procedures by promoting patient relaxation and minimizing movement, thereby improving the precision and efficiency of the intervention.

Therapeutic or diagnostic interventions include, but are not limited to, synchronized cardioversion for the management of arrhythmias, closed reduction of dislocations or fractures, incision and drainage of abscesses, primary closure of lacerations, thoracostomy tube placement for pleural effusions or pneumothorax, extraction of foreign bodies, vascular access establishment for intravenous or intra-arterial administration, and cannulation for hemodynamic monitoring or intervention.

Contraindications

Absolute Contraindications

The urgent need for immediate treatment (e.g., hemodynamic instability) that cannot be delayed for sedation.
Hypersensitivity to the administered drug or its delivery vehicle.
Specific to nitrous oxide: Conditions such as pneumothorax, pneumomediastinum, bowel obstruction, or the presence of an intraocular gas bubble (e.g., following vitreoretinal surgery), where nitrous oxide can expand into air-filled spaces.

Allergy to eggs or soy is no longer considered a contraindication to propofol, as the allergenic components in eggs or soy differ from the moieties used in propofol formulations.

Relative Contraindications

Severe cardiopulmonary disease, which increases the risk of decompensation due to respiratory depression.
Obstructive sleep apnea.
Obesity or anatomical features (e.g., micrognathia, macroglossia, short neck, or congenital anomalies) suggestive of potential difficulties with intubation.
Chronic liver or kidney disease, which may impair drug metabolism and lead to prolonged sedation.
Patients older than 60 years of age, who face an increased risk of decompensation; PSA drug doses should often be reduced.
Acute alcohol or sedative drug intoxication, which heightens the risk of respiratory complications; PSA drug doses should be decreased accordingly.
Chronic alcohol or substance use disorder, which may necessitate an increased PSA drug dosage.
Pre-procedural intake of food or drink; institution-specific protocols regarding fasting prior to PSA should be reviewed.

When any of these relative contraindications are present, consult an anesthesiologist or consider the use of drugs that do not depress respiration (e.g., ketamine) [4, 5].

Although some guidelines recommend postponing elective procedural sedation for several hours after ingestion of clear liquids and for eight hours after ingestion of solids, there is no definitive evidence to support the efficacy or necessity of such measures.

Equipment and Patient Preparation

Choices of Sedative and Analgesic Agents

Always plan to use the minimum number and dosage of sedative and analgesic agents required to achieve the targeted level of sedation. This approach minimizes the risk of adverse drug effects and reduces the likelihood of complications associated with PSA.

“Never use neuromuscular blocking (NMB) agents for PSA.”

The selection of agents may differ based on local protocols or nationwide regulations. It is essential to consult the relevant institutional or regional guidelines. In cases of uncertainty, seek guidance from qualified emergency physicians or anesthetists [6].

Ketamine (IV or IM)
Ketamine can be administered intravenously (IV) or intramuscularly (IM). For IV administration, the loading dose ranges from 0.5 to 2 mg/kg, while for IM administration, the loading dose ranges from 2 to 4 mg/kg. Maintenance dosing is recommended at 0.1 mg/kg IV every 10 minutes. The typical dose for a 70 kg adult is 35 to 70 mg for IV administration and 140 to 280 mg for IM administration.

Fentanyl (IV)
Fentanyl is administered intravenously. The loading dose ranges from 50 to 100 mcg over a period of one minute. Maintenance dosing is 25 mcg every five minutes as required. For a typical 70 kg adult, the dose is approximately 50 mcg.

Midazolam (IV)
Midazolam is administered intravenously. The loading dose ranges from 1 to 2.5 mg IV given over two minutes. Maintenance dosing involves 1 mg every five minutes as required. For a typical 70 kg adult, the usual dose is 1 to 2.5 mg IV or 5 mg IM.

Etomidate (IV)
Etomidate is given intravenously with a loading dose of 0.1 to 0.2 mg/kg. Maintenance dosing is 0.05 mg/kg every five minutes. For a 70 kg adult, the typical dose is 7 to 15 mg IV.

Propofol (IV)
Propofol is administered intravenously with a loading dose ranging from 0.5 mg/kg (in elderly patients) to 1 mg/kg. Maintenance dosing is 0.1 mg/kg every one to two minutes. For a typical 70 kg adult, the loading dose is 35 to 70 mg, with a maintenance dose of 10 mg.

Ketafol (Ketamine + Propofol) (IV)
Ketafol, a combination of ketamine and propofol, is administered intravenously. The loading dose is 0.5 to 1 mg/kg of ketamine, with maintenance dosing of 10 mg of propofol every two minutes. For a 70 kg adult, the ketamine loading dose ranges from 35 to 70 mg IV, and the propofol maintenance dose is 10 mg every two minutes.

Ketamine is considered safe for use in children undergoing procedural sedation and analgesia in the emergency department (ED). Propofol is safe for procedural sedation and analgesia in both children and adults in the ED (LEVEL A).
Etomidate is safe for procedural sedation and analgesia in adults in the ED. Additionally, a combination of propofol and ketamine is safe for procedural sedation and analgesia in both children and adults (LEVEL B) [7].
Ketamine is safe for procedural sedation and analgesia in adults in the ED. Alfentanil is also safe for procedural sedation and analgesia in adults in the ED. Furthermore, etomidate is safe for use in children undergoing procedural sedation and analgesia in the ED (LEVEL C) [8, 9].

Facilities & Equipment

The procedure must be conducted in a facility that is sufficiently spacious and adequately equipped to handle potential cardiopulmonary emergencies. The required resources include:

A room of adequate size to accommodate resuscitation efforts, if necessary.
Adequate lighting for performing procedures safely.
An operating table, trolley, or chair that can be tilted head-down (preferable but not mandatory).
A suction apparatus meeting operating room standards.
A reliable oxygen supply and suitable devices for administering oxygen to a spontaneously breathing patient.
Equipment for lung inflation with oxygen (e.g., a self-inflating bag and mask) and access to a range of advanced airway management tools, including masks, oropharyngeal airways, endotracheal tubes, laryngoscopes, and laryngeal mask airways.
A resuscitation trolley equipped with appropriate drugs and equipment for cardiopulmonary resuscitation.
A pulse oximeter for monitoring oxygen saturation.
A sphygmomanometer or another device for blood pressure monitoring.
Ready access to an electrocardiogram (ECG) machine and a defibrillator.
A reliable means of summoning emergency assistance.

Patient Preparation

Patient preparation is a critical step in ensuring the safety and effectiveness of procedural sedation and analgesia (PSA) in the emergency department. Proper preparation minimizes the risks of complications, enhances patient comfort, and facilitates procedural efficiency [10-12].

A comprehensive pre-procedural assessment is essential to evaluate the patient’s medical history, allergies, and current medications, including over-the-counter drugs, herbal supplements, and recreational substances. Identifying contraindications to sedation, such as a history of adverse reactions to sedatives or anesthetics, is crucial. Patients should be provided with detailed fasting instructions tailored to the type of sedation and their medical condition. Typically, fasting guidelines recommend 6–8 hours for solid food and 2–4 hours for clear liquids to reduce the risk of aspiration. However, many emergency department patients

Informed consent is a cornerstone of patient preparation. Patients or their guardians should receive clear explanations about the procedure, its risks, benefits, and potential alternatives, and written consent should be obtained. It is equally important to address any anxiety or stress by offering reassurance and allowing patients to express concerns. Effective communication and education about what to expect during and after PSA help alleviate anxiety and improve the overall experience. Additionally, patients should be instructed to remove jewelry, dentures, or other loose objects before the procedure and wear comfortable, loose-fitting clothing.

On the day of the procedure, patients must have a responsible adult accompany them to the emergency department and arrange transportation home post-procedure. Intravenous (IV) access should be secured for administering sedatives, analgesics, and potential fluid resuscitation. Continuous monitoring of baseline vital signs, including oxygen saturation, heart rate, and blood pressure, must be ensured throughout the procedure to detect and address any adverse events promptly.

Post-procedure care involves monitoring the patient until they have fully recovered from sedation. Before discharge, patients should be provided with detailed written instructions on post-procedural care, including medication guidance, activity restrictions, and follow-up appointments. A contact number for the emergency department or healthcare provider should also be provided in case of concerns or complications after discharge.

Adhering to these recommendations, including thorough preparation, education, and monitoring protocols, ensures patient safety and comfort, reduces the likelihood of complications, and optimizes the success of PSA in the emergency department

Procedure Steps

General Clinical Management and Documentation

Written documentation of procedural sedation must be completed by the responsible physician or surgeon, covering all phases of the procedure (pre, intra-, and post-procedure).
Documentation should include:
- Names of all staff involved in the procedure.
- Findings from history, physical examination, and investigations.
- Drug dosages and their administration times.
- Vital signs (pulse rate, oxygen saturation, and blood pressure) recorded pre-, during, and post-procedure.

Assessment of Patient Status
The physician in charge should document patient assessment using the American Society of Anesthesiologists (ASA) classification system [13]:

ASA Class 1: Normal healthy patient with no significant systemic disturbances.
ASA Class 2: Patient with mild systemic disease without functional limitations.
ASA Class 3: Patient with severe systemic disease causing some functional limitation.
ASA Class 4: Patient with severe systemic disease posing a constant threat to life.
ASA Class 5: Moribund patient not expected to survive without surgery.
ASA Class 6: Brain-dead patient whose organs are being harvested for donation.

Note: PSA performed by non-anesthesiologists is recommended only for ASA Class 1 and 2 patients.

Indications for Involvement of an Anesthesiologist

The presence of an anesthesiologist may be required for patients at increased risk of airway, respiratory, or cardiovascular compromise, or those prone to serious adverse events during sedation [14]. These include patients with:

Advanced age, particularly with significant co-morbidities.
Significant cardiovascular, pulmonary, renal, or hepatic disease.
Morbid obesity.
Obstructive sleep apnea.
Known or suspected difficult airway/intubation cases.
Acute gastrointestinal bleeding associated with cardiovascular compromise or shock.
Risk of aspiration of gastric contents.
History of adverse events from sedation, analgesia, or anesthesia.
History of substance abuse.

The decision to involve an anesthesiologist should be made by the clinician after carefully weighing the risks to the patient [14].

For non-emergency cases, PSA should adhere to general fasting guidelines to minimize the risk of aspiration during the procedure. The recommended fasting durations vary by age and the type of substance ingested, summarized as the “2-4-6 rule” [15]. For children, the guidelines are as follows: 2 hours for clear fluids, 4 hours for breast milk, and 6 hours for formula milk or solid foods. For adults, the fasting guidelines recommend 2 hours for clear fluids and 6 hours for milk or solids. Clear fluids include water, glucose drinks, cordial beverages, and clear fruit juices. These fasting protocols ensure adequate preparation and safety for PSA in non-emergency settings.

Steps in the Administration of Procedural Sedation [16]

Pre-Procedure

Proper preparation is essential to ensure the safety and success of PSA. The following steps should be undertaken:

Patient Selection: Assess the appropriateness of PSA for the patient based on clinical needs and risk factors.
Patient Assessment: Conduct a thorough review of relevant medical history, physical examination, and investigations as outlined in institutional protocols.
Pre-Procedural Instructions: Provide patients with written instructions on preparation and post-procedural care, including contact details for emergencies. Instructions should be available in multiple languages to enhance accessibility.
Consent: Obtain verbal or written consent according to institutional requirements. In cases of altered mental status or unconscious patients, PSA may proceed without written consent if close relatives provide authorization.
Personnel: Ensure a minimum of two qualified and experienced personnel are present—one to perform the procedure and the other to administer drugs and monitor vital signs.

During the Procedure

To maintain patient safety and achieve the desired sedation level, adhere to the following steps during PSA administration:

IV Access: Establish intravenous access for drug administration and potential resuscitation needs.
Monitoring: Continuously monitor the patient’s vital signs, including pulse oximetry, non-invasive blood pressure (NIBP), and electrocardiography (ECG). Document all findings in accordance with protocol.
Oxygen Administration: Deliver supplemental oxygen using appropriate devices such as nasal prongs or face masks, as indicated.
Drug Administration: Administer sedation drugs exclusively by trained registered medical practitioners or registered dental practitioners.
Continuous Observation: Assign a dedicated assistant to monitor the patient throughout the procedure, ensuring early detection and management of potential complications.

Post-Procedure

Post-procedural care focuses on monitoring recovery, ensuring patient safety, and providing clear discharge instructions:

Documentation: Record all details of the procedure, including the drugs used and vital signs monitored.
Recovery Monitoring: Continue observation of the patient’s vital signs using pulse oximetry and NIBP until full recovery is achieved.
Discharge: Patients should be discharged only when accompanied by a responsible adult. Provide written instructions on post-procedural care.
Reinforce Instructions: Before discharge, verbally review post-procedural care instructions to ensure patient understanding and compliance.

Recommendations for PSA Monitoring by Target Sedation Level

Monitoring requirements vary depending on the desired level of sedation:

Minimal Sedation:

Level of Consciousness: Observe frequently.
Heart Rate: Measure every 15 minutes.
Respiratory Rate: Measure every 15 minutes.
Blood Pressure: Measure every 15 minutes and after sedative boluses.
Oxygen Saturation: Monitor continuously.
Capnography End-Tidal CO2: Not required.

Moderate or Dissociative Sedation:

Level of Consciousness: Observe constantly.
Heart Rate: Monitor continuously.
Respiratory Rate: Continuous direct observation.
Blood Pressure: Record every 5 minutes and after sedative boluses.
Oxygen Saturation: Monitor continuously.
Capnography End-Tidal CO2: Consider continuous monitoring.

Complications

Performing PSA requires close monitoring and is associated with potential adverse events. Numerous analgesic, sedative, and anesthetic agents can be used in combination for PSA in the ED. However, adverse event reporting for PSA has been heterogeneous.

Known complications of PSA include agitation, apnea, aspiration, bradycardia, bradypnea, hypotension, hypoxia, intubation, laryngospasm, and nausea/vomiting [17-19]. Among these, the most frequently observed adverse events are hypoxia, occurring at a rate of 40.2 per 1,000 sedations, followed by vomiting, hypotension, and apnea.

Severe adverse events requiring emergent medical intervention are less common but include aspiration (%0.12), laryngospasm (%0.42), and intubation (%0.16).

The routine use of capnography monitoring during PSA is recommended as it allows earlier detection of hypoventilation and apnea compared to pulse oximetry and/or clinical assessment alone [20]. Studies have shown that the combination of Ketamine and Propofol (Ketofol) results in a lower incidence of adverse events, including agitation, apnea, hypoxia, bradycardia, hypotension, and vomiting, compared to each medication used individually [21].

Although the incidence of serious adverse events during PSA in the ED is rare, it is essential to practice shared decision-making and obtain informed consent, as PSA is not a completely benign procedure [22].

Hints and Pitfalls

Pitfalls of PSA

The common pitfalls of procedural sedation and analgesia are often attributed to inadequate practitioner skills, improper patient selection, or insufficient knowledge of the pharmacological agents being used. When these factors are combined, they may result in either under-sedation or over-sedation, compromising the airway, cardiovascular, or respiratory system, and increasing the risk of adverse outcomes [23-26].

Failure to administer safe and effective PSA can lead to unnecessary complications, heightened anxiety, and delays in the patient’s return to normal function following emergency department procedures. Barriers to achieving optimal PSA outcomes, especially when performed by non-anaesthesiologists, often include knowledge gaps among providers and inadequate efforts toward quality improvement. It is critical that PSA be performed by competent and experienced practitioners who follow established guidelines and standard operating procedures, which should be readily available in all facilities where PSA is conducted (e.g., emergency physicians, internal physicians, surgeons, dental practitioners).

For painful procedures, alternative pain management strategies, such as nerve blocks, should be considered when they are safer and equally effective. Additionally, it is essential to complete a checklist for pre-, intra-, and post-PSA to ensure patient safety and optimize outcomes.

Key Considerations for PSA

Most sedative agents lack significant analgesic effects; therefore, analgesia should be administered beforehand and given sufficient time to achieve its maximal effect prior to administering the sedative agent.
PSA agents and doses should always be tailored to the individual patient, taking into account factors such as age, comorbidities, and the patient’s clinical status. Elderly, debilitated, and acutely ill patients require lower initial doses of sedative agents than healthy young adults.
Sedative agents should be titrated gradually to avoid complications, and sufficient time should be allowed for the sedative to take full effect before starting the procedure.
Regular audits and quality assurance programs should be conducted to monitor and improve PSA practices over time.

Indicators of Sedation Failure

Sedation failure may occur if:

The patient experiences undue discomfort during the procedure.
Adverse events such as hypotension or hypoxia arise.
Prolonged observation is required following the procedure.

Common Pitfalls in PSA Administration [23]

Inadequate provision of analgesia prior to administering sedatives.
Insufficient time allowed for analgesics or sedatives to achieve their maximal effect.
Failure to adjust doses for elderly or chronically ill patients, leading to over-sedation or complications.
Rapid titration of sedative agents, increasing the risk of adverse events.
Premature discontinuation of monitoring or transferring a sedated patient from a controlled environment (e.g., from the procedure room to the x-ray department).
Discharge of patients without adequate supervision or clear written instructions; sedative agents may cause amnesia, making verbal instructions ineffective.
Failure to address the specific needs of vulnerable populations, such as pediatric, geriatric, or pregnant patients, as well as adults with significant comorbidities.

Special Patient Groups

Pediatrics [27,28]

Procedural sedation for pediatric patients requires thorough preparation and specific considerations due to their unique anatomical and physiological characteristics. Consent must be obtained from parents or guardians, except in emergent situations where two senior practitioners may assess and provide consent. Special attention should be given to airway assessment to prevent respiratory compromise. Pharmacological agents with known respiratory adverse effects should be avoided or dosages adjusted as necessary.

Assessment Prior to Procedural Sedation in Children:

Evaluate fasting status.
Perform a focused medical examination, emphasizing airway assessment.
Utilize the American Society of Anesthesiologists (ASA) classification (only ASA I & II patients are considered suitable).
Review previous sedation or general anesthesia experiences and outcomes.

Key Considerations:

A history of severe sleep apnea or airway abnormalities necessitates additional precautions when planning sedation.
Paradoxical reactions, such as increased agitation with benzodiazepines or barbiturates, are more common in younger children.
Adverse effects like agitation upon emergence, diplopia, nausea, and vomiting have been reported with ketamine use.
Selection of sedation agents and administration routes should align with the patient’s individual needs, the procedure type, and the anticipated level of pain.
Early consultation with a pediatric anesthesiologist is recommended for patients with chronic airway diseases or a history of drug-related adverse events.
Discharge should only occur with a responsible adult and comprehensive post-discharge instructions for home observation

Geriatrics [29]

Procedural sedation is generally safe in older adults; however, under-treatment of pain or inadequate sedation should be avoided. Initial assessment must include a thorough review of comorbidities and medication history to identify potential interactions with sedatives or analgesics.

Special Precautions for Geriatric Patients:

Patients with chronic respiratory or cardiovascular diseases require additional monitoring.
Older adults typically require lower doses of sedative agents due to increased sensitivity, slower metabolism, reduced physiological reserves, and smaller volume of distribution.
These patients are at higher risk for oxygen desaturation, but most respond well to supplemental oxygen.

Pregnant Patients [30,31]

Procedural sedation may be appropriate for pregnant patients experiencing significant pain, distress, or requiring surgical intervention, provided it is conducted under the supervision of a physician skilled in obstetric anesthesia. Pregnancy induces hemodynamic changes such as decreased blood pressure (due to vasodilation and aortocaval compression), increased cardiac output, and reduced maternal hematocrit.

Key Considerations for Sedation in Pregnancy:

Exposure to PSA medications is typically brief, with low doses, making significant adverse effects on pregnancy outcomes unlikely.
Over-sedation can lead to maternal hypotension and hypoxia, which may result in fetal hypoxia.
Medications used in PSA can influence uterine activity, placental perfusion, and fetal oxygenation. They may also directly affect fetal heart rate by crossing the placenta or indirectly via maternal hemodynamic changes.

Pharmacological Agents in Pregnancy:

Midazolam: Frequently used due to its rapid onset and short duration. Although it crosses the placenta via passive diffusion, no conclusive evidence suggests it adversely affects fetal development at clinically recommended doses. Animal studies indicate potential effects when combined with other anesthetics.
Propofol: Clinically recommended doses are not associated with fetal defects and are widely used for obstetric and non-obstetric procedures. However, excessive doses may result in fetal depression due to its lipophilic nature and placental transfer.
Ketamine: Generally not recommended due to limited human data. It is known to cross the placenta, and animal studies suggest potential neurotoxicity with prenatal and early postnatal exposure.

Author

Nik Hisamuddin Nik Ab Rahman

Professor Dr. Nik Hisamuddin Nik Ab Rahman graduated with an MBChB from the University of Glasgow in 1994. He completed the Emergency Medicine trainee program (Master of Medicine) at Universiti Sains Malaysia (USM) in 2002. He further honed his expertise as a Clinical Fellow in Emergency Medicine at Edinburgh Royal Infirmary, Scotland, and in Hyperbaric & Diving Medicine at Key Largo, Florida, USA. In 2016, he earned his PhD in Health Informatics & GIS in Health, specializing in road traffic injuries. Professor Nik Hisamuddin spearheaded the development of the Department of Emergency Medicine at Hospital USM, introducing Malaysia’s first Trauma Intensive Care Unit (TICU). He currently serves as the Director of Hospital USM and a Professor in Emergency Medicine and Hyperbaric/Diving Medicine at the School of Medical Sciences, USM. Additionally, he is a committee member of the USM Management Team, the Malaysia National Specialist Registry (Emergency Medicine; 2009–present), and the Specialty Conjoint Committee in the Master of Medicine in Emergency Medicine (2005–2017). He has been awarded numerous research grants from national and international sources. His research and clinical interests include trauma and injury prevention, community life support education, hyperbaric medicine, and acute pain management. He is currently supervising seven PhD and eight Master's candidates, with a focus on Design and Developmental Research (DDR) approaches. With approximately 70 peer-reviewed journal articles to his name, Professor Nik Hisamuddin is a leading figure in his field. His hobbies include traveling, golfing, and shopping.

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Reviewed and Edited By

Arif Alper Cevik, MD, FEMAT, FIFEM

Prof Cevik is an Emergency Medicine academician at United Arab Emirates University, interested in international emergency medicine, emergency medicine education, medical education, point of care ultrasound and trauma. He is the founder and director of the International Emergency Medicine Education Project – iem-student.org, chair of the International Federation for Emergency Medicine (IFEM) core curriculum and education committee and board member of the Asian Society for Emergency Medicine and Emirati Board of Emergency Medicine.