Informed Consent for Intravenous Procedural Sedation and Analgesia

Procedure Name

Form Sections

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Facility Name

Physician Administering Sedation

Provider Performing the Procedure

Patient Full Legal Name

Date of Birth

Patient Weight

Medical Record Number

Date and Time of Procedure

Procedure Requiring Sedation

ASA Physical Status Classification

Fasting Status (NPO)

Planned Sedation Agent(s)

Known Drug Allergies

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Procedural sedation and analgesia (PSA), also called conscious sedation, is a controlled technique of giving IV medications to produce a state of reduced awareness and pain sensitivity while the patient continues to breathe on their own. It is used in the emergency department to make painful or distressing procedures safer and more comfortable. Unlike general anesthesia, the patient is not fully unconscious. The level of sedation is carefully controlled so that the patient can still breathe independently and usually responds to verbal or physical stimulation. Before the procedure begins, an IV line is placed in the patient's arm. Oxygen is provided by nasal cannula or face mask. Continuous monitoring equipment is applied including pulse oximetry, heart rate monitor, blood pressure cuff, and end-tidal CO2 monitoring. The physician gives the sedation medications in small, incremental doses while watching the patient's response closely. Once the procedure is complete, the sedation wears off and the patient is monitored in a recovery area until they meet discharge criteria.

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Section 14signature block

Patient Signature (or Parent/Guardian if minor)

Relationship to Patient (if signing on behalf of patient)

Physician Administering Sedation Signature

Nurse Witness Signature

Date and Time of Consent

Informed Consent for Intravenous Procedural Sedation and Analgesia

Patient and Provider Information

Facility Name

Physician Administering Sedation

Provider Performing the Procedure

Patient Full Legal Name

Date of Birth

Patient Weight

Medical Record Number

Date and Time of Procedure

Procedure Requiring Sedation

ASA Physical Status Classification

Fasting Status (NPO)

Planned Sedation Agent(s)

Known Drug Allergies

What Procedural Sedation Involves

Levels of Sedation

Minimal sedation (anxiolysis): the patient is relaxed and calm but fully awake and able to respond normally. Breathing and reflexes are not affected. Example: low-dose benzodiazepine.

Moderate sedation (conscious sedation): the patient is drowsy and may not remember the procedure clearly but responds purposefully to verbal commands. Breathing is maintained without assistance. Example: midazolam combined with fentanyl.

Deep sedation: the patient is difficult to rouse but still breathes independently. May only respond to repeated or painful stimulation. Example: propofol or ketamine at higher doses.

Dissociative sedation: the patient enters a trance-like state in which they remain awake and have protective reflexes intact but are completely unaware of pain. Example: ketamine. Particularly useful in children and for painful procedures.

Risks and Possible Side Effects

Respiratory depression: IV sedation medications can slow or temporarily suppress breathing. This is the most important risk of PSA. Continuous monitoring detects breathing problems quickly. Equipment and medications to support breathing are immediately available at all times. The physician and nurse are trained in airway management.

Oxygen desaturation: a temporary drop in blood oxygen levels. Supplemental oxygen is given throughout the procedure to reduce this risk.

Airway obstruction: relaxation of the throat muscles may cause partial airway blockage. Repositioning the airway or placing a simple airway support device usually resolves this.

Vomiting and aspiration: if stomach contents enter the airway during sedation, this is a serious complication. Fasting before the procedure reduces this risk. Patients are assessed on their fasting status before sedation is given.

Cardiovascular effects: some sedation agents can lower blood pressure or alter heart rate. Continuous cardiac and blood pressure monitoring detects and allows treatment of these changes.

Emergence reactions (ketamine): a small number of adults receiving ketamine experience vivid dreams, visual hallucinations, or disorientation during or after the procedure. These are usually brief and managed with calm reassurance or a small dose of midazolam.

Prolonged sedation: some patients take longer than expected to fully recover to baseline alertness. The patient will not be discharged until they meet all recovery criteria.

Allergic reaction: rare allergic reactions to sedation medications can occur. Emergency medications and equipment for allergic reactions are available.

IV site complications: bruising, swelling, or pain at the IV insertion site.

Monitoring During the Procedure

The following monitoring will be in place throughout the entire sedation and recovery period: (1) Continuous pulse oximetry to measure blood oxygen level. (2) Continuous cardiac monitoring (ECG or heart rate monitor). (3) Blood pressure measurement every 3 to 5 minutes. (4) End-tidal CO2 monitoring to detect breathing changes early. (5) Ongoing clinical observation by a dedicated nurse or physician whose sole responsibility during the procedure is to monitor the patient's sedation level and vital signs. Resuscitation equipment, oxygen delivery devices, suction, and reversal medications (flumazenil for benzodiazepines, naloxone for opioids) are immediately available.

Recovery and Discharge Criteria

The patient will remain under observation after the procedure until all of the following criteria are met: (1) Alert and oriented to person, place, and time. (2) Breathing comfortably without supplemental oxygen. (3) Vital signs stable and within acceptable range. (4) Able to swallow without difficulty. (5) Minimal or no nausea or vomiting. (6) Pain adequately controlled. After discharge, the patient must be driven home by a responsible adult. The patient must NOT drive, operate heavy machinery, or make important legal or financial decisions for at least 12 to 24 hours after sedation. The patient must have a responsible adult with them for at least 4 to 8 hours after discharge.

Alternatives to Procedural Sedation

Local or regional anesthesia alone: numbing the area directly without any sedation. Suitable for some procedures but may not provide adequate comfort for more painful or distressing interventions.

IV analgesia without sedation: strong pain medications alone without sedation. May allow the procedure to be completed with less discomfort but the patient remains fully awake.

General anesthesia in an operating theater: reserved for procedures that cannot be safely performed under PSA or when the airway needs to be secured. Involves higher risk and longer recovery.

Deferral of the procedure: in some non-urgent situations, the procedure may be postponed until the patient can be adequately prepared and fasted.

Fasting Status Acknowledgment

I confirm that my last meal, food intake, and fluid intake are accurately documented above. I understand that fasting before procedural sedation reduces but does not eliminate the risk of aspiration. I understand that if my fasting status is inadequate, the physician may delay the procedure, use a different sedation technique, or in emergency situations, use the lowest effective sedation dose while accepting an increased aspiration risk.

Right to Refuse Sedation

The patient has the right to decline sedation and to request that the procedure be performed with local anesthesia alone or deferred. The provider will explain the implications of this choice. Refusing sedation does not prevent the patient from receiving pain management by other means.

Patient Understanding

I confirm that I have read this consent form or had it explained to me. I have asked questions about the sedation plan, the monitoring, the risks, and what to expect during recovery. All my questions have been answered. I understand that I must not drive or make important decisions for at least 12 to 24 hours after the procedure and that I must have a responsible adult take me home.

Language Access

If English is not your main language, a qualified interpreter is available at no cost. Please notify staff before any treatment begins.

Copy of Consent

I acknowledge that I have been offered a copy of this signed consent form for my records.

Patient Authorization

I voluntarily agree to receive procedural sedation and analgesia as described in this form for the purpose of completing the procedure listed above. I confirm that my fasting status is accurately reported. I understand and accept the risks, including the risk of respiratory depression and aspiration. I agree to be driven home by a responsible adult and to follow all post-sedation restrictions.

Signatures and Verification

Patient Signature (or Parent/Guardian if minor)

Relationship to Patient (if signing on behalf of patient)

Physician Administering Sedation Signature

Nurse Witness Signature

Date and Time of Consent

Document ID: CC-PENDING

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