UNIVERSITY HOSPITAL
Augusta, Georgia
PATIENT CARE PRACTICE STANDARDS
Division or Department:
PATIENT CARE SERVICES
Subject:
MODERATE SEDATION PROTOCOL
I.
No.
6010-031
Page
1 of 9
Effective
11/94
Approval
Revised
*3/10
With 2 Attachments
POLICY STATEMENTS
A.
This practice standard is to be followed when pharmacologic agents are given in
conjunction with a procedure and the intent is to obtund, dull or reduce the
awareness of pain. Procedures for which moderate sedation may be used include,
but are not limited to, dental, minor surgery, endoscopy, radiology, elective
cardioversion, interventional cardiac procedures, cardiovascular lab procedures,
ER procedures (fracture reductions), lithotripsy, SCN procedures such as
opthalmological procedures.
B.
Medications will be administered by RNs, RCIS, Radiology Technologists, or LPNs
who are competent in moderate sedation medication administration. The medication
will be administered in the presence of a physician with moderate sedation privileges.
Deep sedation and anesthesia will be administered by a physician or CRNA
privileged to do so.
C.
An RN will be responsible for managing the care of the patient recovering from
moderate sedation. Staff providing care to the moderately sedated patient will
demonstrate competence in providing moderate sedation care. Staff will have no
other responsibilities that would leave the patient unattended during administration of
moderate sedation and until patient has control of airway. During recovery, staff will
maintain continuous monitoring until patient meets discharge criteria (see Patient
Care Practice Standard #6010-054, Post Procedure Discharge Criteria).
D.
Definitions
Because degrees of sedation occur on a continuum, it is necessary to define the four
levels of sedation and anesthesia.
1.
Minimal sedation (anxiolysis) – This policy does not apply to minimal
sedation.
A drug-induced state during which individuals served respond normally to
verbal commands. Although cognitive function and coordination may be
impaired, ventilatory and cardiovascular functions are unaffected.
The administration of medications is for the reduction of anxiety.
In this stage, the following should be present:
a.
Normal respirations.
*For additional revision dates, see end of PCPS.
Patient Care Practice Standard #6010-031
Moderate Sedation Protocol
2.
Page 2 of 9
b.
Normal eye movements; and
c.
Intact protective reflexes.
Amnesia may or may not be present. The patient is technically awake, but
under the influence of the drug administered.
Moderate sedation/analgesia
A drug-induced depression of consciousness during which individuals served
respond purposefully to verbal commands, either alone or accompanied by
light tactile stimulation. No interventions are required to maintain a patent
airway, and spontaneous ventilation is adequate. Typically no interventions
are required to maintain cardiovascular function.
Moderate sedation is the proper administration of pharmacological agents, in
conjunction with a treatment or procedure, with the intent to obtund, dull, or
reduce the awareness of pain without loss of protective reflexes. However, it
must be remembered that the risk of loss of protective reflexes exists.
Moderate sedation of the patient is generally achieved when there is slurred
speech but the patient is arousable and is able to respond. The drugs,
dosages, and techniques utilized are not intended to produce loss of
consciousness. Moderate sedation begins when a patient perceives
significant alteration in mood or awareness or when changes are apparent to a
trained observer. Although unintended, moderate sedation can result from
minimal amounts of drugs given for minor procedures. If present by intent or
otherwise, the presence of moderate sedation demands the same degree of
observation and monitoring.
3.
4.
Protective Reflexes – Autonomic and sensory-motor physiologic reflexes that
serve to maintain the patient’s homeostatic wellness. These reflexes include,
but are not limited to, patent airway, breathing, gagging, coughing, blinking,
neurological stability, etc.
Deep sedation/analgesia
A drug-induced depression of consciousness during which individuals served
cannot be easily aroused but respond purposefully following repeated or
painful stimulation. The ability to independently maintain ventilatory
function may be impaired. Individuals served may require assistance in
maintaining a patent airway and spontaneous ventilation may be inadequate.
Typically no interventions are required to maintain cardiovascular function.
Anesthesia
Consists of general anesthesia and spinal or major regional anesthesia. It
does not include local anesthesia. General anesthesia is a drug-induced loss
of consciousness during which individuals served are not arousable, even by
painful stimulation. The ability to independently maintain ventilatory
function is often impaired. Individuals served often require assistance in
Patient Care Practice Standard #6010-031
Moderate Sedation Protocol
Page 3 of 9
maintaining a patent airway, and positive pressure ventilation may be
required because of depressed spontaneous ventilation or drug-induced
depression of neuromuscular function. Cardiovascular function may be
impaired.
II.
E.
Anesthesia Involvement
At times the anesthesiologist or CRNA may be administering moderate sedation,
particularly if deep sedation is needed for the procedure or if the patient is high risk.
The anesthesiologist or CRNA administers medications which may or may not be
typically used for moderate sedation (e.g. Versed, propofol). However, all of these
medications are short-acting agents. Anesthesia remains with these patients until they
regain control of their airway. Unless the physician orders otherwise, these patients
are recovered according to the procedure outlined below for moderate sedation.
F.
Exclusions
1.
This practice standard does not address preoperative medications, pain
management or anxiolysis.
2.
The use of these medications in emergency procedures and/or other
interventions where the airway and/or other protective reflexes are
intentionally blunted but protected by endotracheal intubation or other
measures (i.e. ventilator patients, rapid sequence intubation) are also
excluded from this practice standard.
3.
Pediatric patients receiving a total dose of less than 50 mg/kg P.O. of Chloral
Hydrate (Noctec) (light sedating dose) will not be considered moderate
sedation.
4.
Pediatric patients (neonates excluded) receiving a total P.O. dose of less than
0.2 mg/kg Midazolam (Versed) will not be considered moderate sedation.
PROCEDURE
A.
The following pre-sedation assessments must be performed by the physician and
documented prior to procedure.
American Society of Anesthesiologist’s (ASA) Physical Status Classification for
Adults and Pediatrics
1.
ASA Class
Description
Class 1
A normal health patient
Class 2
A patient with mild systemic
Disease – no functional limitations
Class 3
A patient with severe systemic
disease-definite functional l
Patient Care Practice Standard #6010-031
Moderate Sedation Protocol
2.
Page 4 of 9
Class 4
A patient with a severe systemic
disease that is a constant threat
to life
Class 5
A moribund patient who is not
expected to survive without the
operation
E
Emergency
ASA Physical Status Classification – is a well-documented guideline for
classifying the physical status of an adult or a pediatric patient according to
the American Society of Anesthesiologists. For neonates, a revised
classification is necessary:
Revised Physical Classification for Neonates
Class I
A normal healthy neonate (Well Baby Nursery)
Class II
A neonate with intact protective reflexes (e.g. with
temperature control, on room air (off respiratory support)
and tolerating full strength/volume formula. This patient
does not require cardiorespiratory or SpO2 monitoring.
Class III
Class IV
A neonate with incomplete/immature or nonexistent
protective reflexes requiring multi-system support (e.g.
temperature, respiratory, and nutritional support, etc.)
A neonate in Class III above who also has irreversible
deterioration.
B.
Anesthesiology Department will be consulted for patients when the procedurist feels
there may be problems with sedation.
C.
The physician determines:
1.
Medications and dosage based on procedure and patient response
2.
NPO status based on procedure to be performed and type of medication to
be given.
D.
Physician and staff providing care for the moderately sedated patient ensure that
patient identification and procedure and site (if applicable) verification are
confirmed prior to the beginning of the procedure as part of the timeout process.
E.
Staff providing care for the moderately sedated patient will ensure that:
1.
IV is patent and that intravenous access is continuously maintained in the
moderately sedated patient
EXCEPTION: Pediatric patients receiving PO/IM sedation
Patient Care Practice Standard #6010-031
Moderate Sedation Protocol
2.
3.
4.
5.
6.
Page 5 of 9
Emergency equipment is immediately accessible to every location where
moderate sedation is administered, and includes at least the following:
a.
Suction
b.
Oxygen
c.
ECG monitor/defibrillator
d.
Airways (e.g. oral or nasal airways)
e.
Emergency drugs, including appropriate reversal agents
f.
Intubation equipment
g.
Telephone to call for help
Patient has nothing in mouth that might obstruct the airway (e.g. gum,
food) and that patient has been NPO
Pulse oximetry with both digital and auditory displays is applied
EXCEPTION: auditory displays are not required in areas where a staff
member is dedicated to monitoring visual display, e.g. CVIS.
ECG monitor is applied when the History & Physical includes cardiovascular
disease, dysrhythmias, and/or hypertension (whether or not medically
controlled)
Patient is monitored continuously
F.
Pre-procedure documentation will contain the following:
1.
History and Physical (dictated or hand-written) must be on medical record
2.
Time of last oral intake, NPO status
3.
Proper consents signed
4.
Name of the procedure
5.
Baseline vital signs and oxygen saturation
6.
Level of sedation
7.
Monitoring equipment used
8.
Pre-sedation assessment to include an airway assessment conducted by
physician and plan for anesthesia developed by physician
9.
Timeout completed
G.
Document level of sedation, pain, vital signs, including blood pressure, pulse rate,
respirations, and oxygen saturation immediately prior to administering medication.
Sedation Scale:
1.
Awake and alert
2.
Occasionally drowsy, easy to arouse
3.
Frequently drowsy, arousable, drifts off to sleep during conversation
4.
Somnolent, minimal response to stimuli
H.
During the procedure and recovery phase, document:
1.
Medications given
2.
Patient response to medications and procedures
Patient Care Practice Standard #6010-031
Moderate Sedation Protocol
Page 6 of 9
3.
4.
Any complications
Level of sedation, pain, pulse, BP, respirations, and pulse oximetry every
15 minutes until the patient is at least at level 2 for 30 minutes or, for
patients who remain at level 1, it has been at least 30 minutes since
administration of the last sedating medication.
Note: BP is not monitored on children less than 5 years of age unless ordered by
the physician.
I.
If the patient slips into a deep state of sedation (i.e. depressed consciousness or
unconsciousness), intervene appropriately. Reversal agents may be necessary if
patients slip from moderate sedation to deep sedation. Actions of reversal agents
are generally short-lived compared to the medications used for sedation. Staff
must be prepared to administer additional dosages of reversal agents until duration
of action of sedative medication is past.
1.
If sedation reversal agents have been given, monitor the patient for 2 hours
after sedation reversal administration. Document sedation level, pain, pulse,
BP, respirations and pulse oximetry every 15 minutes during the 2-hour
recovery.
2.
Be aware that as the stimulus is removed and the doctors and procedure team
have left the bedside, the patient may start to relax and the sedative may have
a more pronounced effect.
J.
Report significant variations in physiologic parameters to the physician and/or nurse
practitioner immediately. These include, but are not limited to, a significant variation
in BP, pulse or oxygen saturation, hyperpnea, apnea, hypoventilation, temperature
instability, inability to arouse the patient, the need to maintain the patient’s airway
mechanically, and other unexpected patient responses.
K.
Discharge patient per individual physician order or discharge patient per physician
order to discharge when appropriate criteria are met (see Patient Care Practice
Standard #6010-054, Post Procedure Discharge Criteria).
L.
Upon discharge, provide the patient or the responsible person with verbal and written
instructions regarding diet, medications, pain management activities, and signs and
symptoms of complications with course of action to take if any complication
develops.
M.
Document post-procedure education, discharge criteria met by patient and
discharge on Moderate Sedation/Procedure Flowsheet or approved computerized
documentation.
Patient Care Practice Standard #6010-031
Moderate Sedation Protocol
III.
Page 7 of 9
SPECIAL CARE NURSERY (SCN)
Patients in the SCN are unique in that the majority do not have protective reflexes. Their
immaturity and/or multi-system illnesses prevent them from establishing or exhibiting the
usual protective reflexes seen in adults. Inherently, these patients receive continuous
cardiorespiratory monitoring, SpO2 monitoring, airway management, and a team of
dedicated, in-unit caretakers (nurse, respiratory therapist, advanced practice nurse, and
neonatologist). Therefore, these patients are not within the definition of moderate sedation
when they receive pharmacological agents for a procedure
IV.
V.
COMPETENCY ASSESSMENT
A.
The RN, RCIS, Radiology Technologist or LPN administering medication or
monitoring the moderately sedated patient is required to
1.
Be ACLS, PALS, or NRP certified as appropriate for age of patient.
2.
Be familiar with proper dosages, administration, adverse reactions, and
interventions for adverse reactions and overdoses.
3.
Know how to recognize an airway obstruction and demonstrate skills in
airway management.
4.
Recognize abnormal and/or significant variations in physiological
parameters.
5.
Have the knowledge and skills to intervene in the event of complications
B.
Initial competency assessment requires demonstration of required knowledge and
skills during moderate sedation for each age group required (adult/geriatric,
pediatric/adolescent, and neonate).
Subsequently, competency is assessed annually as part of the evaluation process, e.g.
Skill and Abilities Check List.
PERFORMANCE MEASURES
Outcome indicators of sedation level = 4, drug used and amount, reversal agents, airway
management, physician and RN caring for patient, and complications related to moderate
sedation will be collected and analyzed quarterly.
All negative outcomes will be evaluated. Quarterly reports will be submitted to CMO,
Practice Committee, and the Department of Anesthesia. Appropriate actions will be taken
and will be dependent upon patterns and trends.
Patient Care Practice Standard #6010-031
Moderate Sedation Protocol
Page 8 of 9
References:
American Academy of Pediatrics Committee on Drugs. (Oct, 2002). Guidelines for
monitoring and management of pediatric patients during and after sedation for diagnostic and
therapeutic procedures. Pediatrics, 110 (4).
American Society of Post Anesthesia Nurses (2004). The role of the registered nurse in the
management of patients receiving IV conscious sedation. ASPAN standards of post anesthesia
nursing practice. Richmond, VA.
Consensus Statement for the Prevention & Management of Pain in the Newborn (2001)
Archives of Pediatric & Adolescent Medicine, 155.
The Joint Commission, Comprehensive Accreditation Manual for Hospitals (current edition)
Kost, M. (2004). Moderate Sedation/Analgesia: Core Competencies for Practice. St. Louis,
MO: W.B. Saunders.
Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists, Anesthesiology,
2002; 96: 1004-1017, American Society of Anesthesiologists, Inc. Lippincott – Raven.
Additional revision dates: 5/99, 11/99, 1/01, 10/02, 3/03, 2/04, 1/05, 3/07,8/08
Patient Care Practice Standard #6010-031
Moderate Sedation Protocol
Page 9 of 9
Approved by:
Department of Anesthesiology
Ken Smith M.D., Chair
__________________________________
Signature
__________
Date
Practice Committee
Charles Spurr M.D., Chair
__________________________________
Signature
________________
Date
Department of Cardiology
Faiz Rehman M.D., Chair
__________________________________
Signature
________________
Date
Department of Radiology
Kent Johnson M.D., Chair
__________________________________
Signature
________________
Date
Special Care Nursery
__________________________________
Cecil Sharp M.D., Medical Director
Signature
________________
Date
Cardiac Cath Lab Committee__________________________________
Faiz Rehman M.D., Chair
Signature
_________________
Date
Division of Gastroenterology __________________________________ _________________
Paul Schwartz M.D., Chair
Signature
Date
ATTACHMENT A
ADULT MEDICATION GUIDELINES FOR MODERATE SEDATION
I.
MEDICATION
NARCOTICS
DOSAGE
ADMINISTRATION
INTERACTION
INCOMPATIBILITIES
REVERSAL AGENT
A. Meperidine
(Demerol®)
Dose will vary; titrate to needs
of patient as ordered by
physician.
Dilute to 10mg/ml for IV
administration; infuse very slowly
over 3-5 min
Effects may be increased when
given with other CNS depressants.
B. Morphine
Adults 1.5-2.5 mg IV
administered every 5-10 minutes
until desired response
Dilute to 10mg/10 ml with SW
and administer very slowly over 5
minutes.
Dose & interval will depend on
clinical situation.
Effect may be increased when
given with other CNS depressants.
Give Narcan or Revex as
ordered.
C. Butorphanol Tartrate
(Stadol®)
0.5-2 mg IV
Administer over 3-5 minutes.
May also be administered IM.
Effects increased when given with
barbiturates or tranquilizers.
Give Narcan or Revex as
ordered.
D. Fentanyl
(Sublimaze®)
0.5-1 mcg/kg (up to 100 mcg)
IV
Administer over 3-5 minutes.
Rapid administration may result in
apnea or respiratory paralysis.
Effects may be increased when
given with other CNS depressants.
Give Narcan or Revex as
ordered.
Healthy adult: 5 mg IV (max 20
mg)
Elderly/debilitated patient: 2
mg-5 mg IV
Do not inject into small veins.
Inject slowly at least one minute
(5 mg/min).
Choose port as close to vein as
possible
Contraindicated in acute narrow
or open angle glaucoma UNLESS
patient is receiving therapy.
Give over 2-3 minutes - stop if
speech becomes slurred
May be diluted with D-5-W or NS
to max concentration of 0.25
mg/ml (1 mg in 4 ml or 5 mg in
20 ml )
Hypersensitivity.
Give Narcan or Revex as
ordered.
II. BENZODIAZEPINES
A. Diazepam
(Valium®)
B. Midazolam
(Versed®)
Healthy adults <60 years of age:
1 mg- 2.5 mg IV
Adults >60 years or debilitated:
1 - 1.5 mg IV
For all patients, start with 1 mg,
wait 2 minutes, then titrate
slowly while monitoring
sedative effect (particularly
slurred speech)
Administer Romazicon as
ordered.
Administer Romazicon as
ordered.
MEDICATION
III. OTHER
A. Promethazine
(Phenergan®)
DOSAGE
12.5 mg -50 mg IV
ADMINISTRATION
Dilute dose to 10 ml with Normal
Saline prior to IV administration.
Administer over one minute.
(No faster than 25 mg/min)
Incompatible with Morphine and
Dilantin. Potentiates CNS
depressant effects of narcotics,
anesthetics and barbiturates.
Effects potentiated by
antidepressants, antihistamines
and phenothiazines.
B. Atropine
0.4-0.6 mg IV
Administer over one minute.
C. Etomidate
(Amidate®)
Only anesthesiologists,
CRNA, or ED
physician may
prescribe this drug.
0.1mg/kg IV for bolus dose
May repeat
Total dose should not exceed
0.3 mg/kg.
Administer over 30-60 seconds
A. Nalmefene
(Revex®)
Cardiac and blood pressure
monitoring required
OVERDOSE
Dilute 1:1 before administration
0.5 mg IV, may repeat with 1
mg in 2-5 minutes
(max 1.5 mg)
May also be administered IM/SC
REVERSAL
0.25 mcg/kg IV, followed by
0.25 mcg/kg incremental doses
at 2-5 minute intervals
(max dose 1mcg/kg)
B. Naloxone
(Narcan®)
0.1-0.2 mg IV given slowly
according to patient response.
If inadequate reversal after 3-5
minutes, may repeat until
reversal complete
Onset of action: 1-2 minutes
Max 10 mg
Fentanyl decreases etomidate
elimination
Verapamil may increase
anesthetic and respiratory effects
(Not recommended for children
under 10.)
IV. REVERSAL AGENTS
INTERACTION
INCOMPATIBILITIES
Excessive dosage may result in:
Increased BP due to pain response
Too rapid reversal causes N&V,
diaphoresis or tachycardia
Excessive dosage may result in:
Increased BP due to pain response
During reversal vital signs should
be monitored closely
Use with caution in patients with
cardiac irritability
Important to monitor patient for
respiratory depression due to
resedation
During reversal vital signs should
be monitored closely
Too rapid reversal causes N&V,
diaphoresis or tachycardia
Use with caution in patients with
cardiac irritability
Half-life: 1-1.5 hours
Important to monitor patient for
respiratory depression due to
resedation after administration
REVERSAL AGENT
None. Use supportive
measures as indicated.
None. Use supportive
measures as indicated.
None. Use supportive
measures as indicated.
MEDICATION
C. Flumazenil
(Romazicon®)
DOSAGE
OVERDOSE
0.2 mg IV over 30 seconds; may
repeat with dose of 0.3 mg over
30 seconds if desire response not
achieved after 30 seconds
Further doses of 0.5 mg can be
administered over 30 seconds at
1 minute intervals
ADMINISTRATION
INTERACTION
INCOMPATIBILITIES
Most Common: nausea and
vomiting, shivering, flushing and
sweating.
Important that Romazicon be
titrated to control awakening of
the patient.
Serious: convulsions in patients
who rely on BZDs to control
seizures.
Administration of a single large
bolus dose can result in confusion
and agitation.
Half-life: 15-60 minutes
Max cumulative dose of 3 mg
REVERSAL
0.2 mg IV over 15 seconds ;after
45 seconds, another dose of 0.2
mg can be given and repeated at
60-second intervals
Max cumulative dose of 1 mg
REVERSAL AGENT
Romazicon should not be
substituted for an adequate period
of post-procedure monitoring.
Romazicon has not been shown to
effectively reverse
hypoventilation from BZD;
therefore, patients should be
monitored for resedation,
respiratory depression or other
residual BZD effects for
approximately two hours after
administration of Romazicon.
If resedation occurs, repeat
dosage of 0.2 mg one minute
every 20 minutes; not to exceed
3 mg in one hour
Propofol (Diprivan) (administered by anesthesiologists and CRNAs only)
Sedation: initiation, 100-150 mcg/kg/min IV infusion for 3-5 min; may be followed by maintenance infusion
Administration
 Supplied in ready-to-use vials. May be further diluted only with D5W to a concentration not less than 2 mg/mL
 Variable rate IV infusion technique preferable to intermittent bolus technique for maintenance of monitored anesthesia care sedation
 Maintain strict aseptic technique during handling
 Dosage and rate of administration should be individualized and titrated to desired effect, according to clinically relevant factors including preinduction and concomitant
medications, age, ASA physical classification, and level of debilitation of the patient
Monitoring
 These patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation
ATTACHMENT B
PEDIATRIC GUIDELINES FOR MODERATE SEDATION
MEDICATION
I. Narcotics
A. Morphine
B. Fentanyl
(Sublimaze®)
II. Benzodiazepines (BZD)
A. Diazepam
(Valium®)
Table updated 3/07
DOSAGE
ADMINISTRATION
INTERACTION /
INCOMPATIBILITIES
REVERSAL AGENT
Neonate/ Infants/ Children
IV/IM/SC 0.05-0.2 mg/kg
(max single dose is 10 mg)
IV: dilute 1:1 with sterile water
Effect may be increased when
given with other CNS depressants
Naloxone
Neonates & Infants < 1 yr.,:
IV 1-4 mcg/kg/dose
Onset of Action – IV: almost immediate
Duration – IV: 30-60 min.
Naloxone
Children 1 – 12 yrs:
IV/IM 1-3 mcg/kg/dose (max
dose 100 mcg/dose)
IV with Midazolam: 1-2
mcg/kg/dose
Administer over 3-5 minutes
Neonates may be more sensitive to
respiratory depression caused by
rapid infusions. Respiratory
depression may persist beyond the
period of analgesia. Skeletal
muscle paralysis, chest wall rigidity
& laryngospasm have been
associated with rapid infusion.
Give IV slowly over 3 minutes.
No analgesic properties.
Flumazenil
Infants/Children:
PO: 0.2-0.3 mg/kg (max
10mg)
Use port closest to vein.
Incompatible with everything.
Do not mix with any drugs.
IV: 0.05mg-0.2 mg/kg
(max single dose: 5mg IV)
Give oral dose 90 min prior to procedure.
Neonates:
IV: 0.04 mg - 0.2 mg/kg
Administer over 5 minutes
IM route not recommended.
MEDICATION
DOSAGE
B. Midazolam
(Versed®)
Neonates:
IV/IM: 0.05 mg- 0.15
mg/kg/dose
(max dose 0.4 mg/kg)
PO: 0.25 mg/kg/dose
Intranasal: 0.2-0.3 mg/kg
ADMINISTRATION
INTERACTION /
INCOMPATIBILITIES
REVERSAL AGENT
IV: Administer over at least 5 min.
Intranasal: Use 5mg/ml injectable preparation to
minimize dosage volume. Draw up dose in 1 ml
syringe and instill 2 drops in each nare until total
dose given. Causes burning.
No analgesic properties.
Flumazenil
Infants/Children:
The oral preparation is 2mg/ml
IV: 0.025 mg- 0.1 mg/kg
titrate to effect (max 0.4
mg/kg, or 6 mg in child < 6
yrs, 10 mg in 6 yrs & >)
IM: 0.1-0.2 mg/kg/dose (max
dose = 10 mg)
PO: 0.25 - 0.5 mg/kg; give 3045 min prior
(max 15mg)
Intranasal: 0.2-0.5
mg/kg/dose, max dose 7.5 mg
C. Lorazepam
(Ativan®)
Neonates/Infants/Children:
IV: 0.05-0.1 mg/kg/dose
Max single dose 4 mg IV
IM: 0.1 mg/kg (max 4 mg)
Give 90-120 min prior to
procedure
III. Chloral Hydrate
(Noctec®)
Neonates/Infants < 1 yr.:
PO: 25-75 mg/kg/dose
Infants 1yr & Children:
PO: 25-100 mg/kg; may
repeat in 30 min (max
1gm/dose infants, 2 gm/dose
children)
Neonates: dilution made by Pharmacy (conc = 0.2
mg/ml); contains benzyl alcohol (dilution will
decrease amount of benzyl alcohol per dose)
IV: administer over 3-5 minutes
PO: Draw up dose in oral syringe; should be diluted
with cola or juice to increase palatability, administer
after feeding to reduce gastric irritation.
Peak effect 30 min -1hr
Use lower dose when using with
opioids. Monitor for respiratory
depression and hypotension.
Seizure-like myoclonus has been
reported in infants following rapid
bolus administration.
May cause resp depression/arrest
requiring mechanical ventilation.
Contains propylene glycol &
benzyl alcohol (may cause seizures
in preterm neonates). Rhythmic
myoclonic jerking has been
reported in premature infants and
newborns.
Flumazenil
Has no analgesic effect.
None. Use supportive
measures as indicated.
Watch for paradoxical excitement,
hypotension, and myocardial/resp
depression.
(Chronic administration in neonates
can lead to accumulation of active
metabolite & arrhythmias.)
MEDICATION
DOSAGE
ADMINISTRATION
INTERACTION /
INCOMPATIBILITIES
IV. Pentobarbital
(Nembutal®)
Limited information is
available for infants less than
6 months of age
Children more than 18
months: I.V.: Initial: 2 mg/kg,
additional doses of 1-2 mg/kg
may be given every 5-10
minutes until adequate
sedation is achieved;
maximum total dose: 6 mg/kg
or 150-200 mg; mean total
dose required (for CT scan
sedation): 3.3-4.5 mg/kg
IV: onset 1 minute; inject slowly; titrate to response
Has no analgesic effect.
None. Use supportive
Metabolism is prolonged in children measures as indicated.
with hepatic disease & shortened in
patients receiving long term
Phenobarbital for epilepsy.
IM: 2-3 mg/kg
(maximum dose of 100 mg)
IM: onset 5-7 minutes; duration 12-25 minutes
V. Ketamine
(Ketalar ®)
IV: 0.5 mg – 1 mg/kg
(maximum dose of 100 mg)
For larger patients start with
100 mg; may redose at 50 mg
increments when initial dose
wears off
For prolonged procedures, redose at 1 mg/kg
PO: 4-6 mg/kg give 30 min
prior to procedure
IM: onset 10-25 minutes
IV: administer over 60 seconds (not to exceed 0.5
mg/kg/min);onset 1 minute; duration 5-10 minutes,
Risk of inducing general anesthesia is high with IV.
Patient must be on a pulse oximeter & be receiving
O2 by nasal cannula. Physician must be present
when given. Must be prepared to handle any airway
emergency and have oral airway and bag valve mask
present.
Usually given with Robinul® & Versed® as
outlined below
PO: may dilute injectable product in beverage and
give orally
May cause laryngospasm and
stimulate salivary secretions.
Avoid in patients with increased
ICP.
Rapid IV admin may result in resp
depression or enhanced pressor
response
Emergence reactions and
hallucinations occur in 12% of
patients (more common in older
children and seen less with IM
admin)
Concurrent use of thyroid hormone
may produce HTN and tachycardia
When using ketamine for sedation, midazolam (blocks potential emergence reactions) and glycopyrrolate (dries secretions) are often used concomitantly
REVERSAL AGENT
None. Use supportive
measures as indicated.
Have Romazicon
available to reverse the
sedation of Versed if
necessary.
University Hospital ER protocol for Triple Drug Regimen:
Drug
IM Dose
IV Dose
Ketamine
3-4 mg/kg
1-1.5 mg/kg
(max dose 100 mg; for larger patients, start with 100 mg and redose at 50 mg increments when initial
dose wears off; for prolonged procedures, re-dose at 1 mg/kg)
Glycopyrrolate
(Robinul®)
0.005 mg/kg
0.005 mg/kg
(min dose 0.1 mg; max 0.2 mg)
Midazolam
(Versed®)
0.05 mg/kg
0.03-0.05 mg/kg
(max dose 1 mg)
If given IM, give all medications in one Syringe.
If given IV, give glycopyrrolate (Robinul®) first, followed by midazolam (Versed®), flush and wait 1 minute, then give the Ketamine slow IV push.
REVERSAL AGENTS
DOSAGE AND ADMINISTRATION
SIDE EFFECTS
MONITORING PARAMETERS /
PRECAUTIONS
Naloxone (Narcan®)
Neonates (including premature)/ Infants/
Children 20 kg or less:
IV/IM/Subcut: 0.1 mg/kg/Dose, repeat 0.01
mg/kg prn q 2-3 min
Excessive dosage of Narcan may result in:
High blood pressure due to pain response.
Too rapid reversal causes nausea and
vomiting, diaphoresis or tachycardia
During reversal, vital signs should be
monitored closely.
Children > 20 kg: IV: 2 mg dose
with subsequent doses of 0.01 mg/kg q2-3 min,
max dose 10mg
Use with caution in patients with
cardiac irritability.
- 60 min;
important to monitor for resp
depression due to resedation
In non-arrest situation, use lowest dose effective
- 0.001mg/kg/dose
ET: dilute 2 mg to 3-5 mls with NS, may require
2-10 times the IV dose
Onset of action: 2 – 5 minutes
If after 3-5 minutes inadequate reversal, may
repeat until reversal complete
Flumazenil (Romazicon®)
Neonates:
Little information available concerning use in
infants & neonates - supportive measures used
in this patient population.
Most common: nausea and vomiting,
shivering, flushing, and sweating.
Serious: convulsions in patients who rely on
BZDs to control seizures.
Children:
IV: 0.01 mg/kg/dose, can repeat 0.01 mg/kg
after 45 sec & q 1-2 min to max cumulative dose
of 1 mg, max single dose = 0.2 mg
References Used:
Harriet Lane Handbook - 16th edition
Pediatric Dosage Handbook – 9th Edition
NeoFax - A Manual of Drugs Used in Neonatal Care – 2003
Pediatric Procedural Sedation and Analgesia – 1999
Acute Pain in Children, Pediatric Clinics of North America, June 2000
Flumazenil has not been shown to
effectively reverse hypoventilation
from BZD, therefore, patients should
be monitored for resedation, respiratory
depression or other residual BZD
effects for approximately two hours
after administration of flumazenil
Duration of action is 45-60 min.