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## Complete Summary

#### GUIDELINE TITLE

Evidence-based care guideline for anesthesia, analgesia and sedation
following arterial switch operation.

#### BIBLIOGRAPHIC SOURCE(S)

Cincinnati Children\'s Hospital Medical Center. Evidence based care
guideline for anesthesia, analgesia and sedation following arterial
switch operation. Cincinnati (OH): Cincinnati Children\'s Hospital
Medical Center; 2006 Jan 10. 8 p. \[16 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Cincinnati Children\'s
Hospital Medical Center. Evidence based clinical practice guideline for
anesthesia, analgesia and sedation following arterial switch operation.
Cincinnati (OH): Cincinnati Children\'s Hospital Medical Center; 2001
Jan 22. 8 p.

Once the guideline has been in place for four years, the development
team reconvenes to explore the continued validity of the guideline. This
phase can be initiated at any point that evidence indicates a critical
change is needed.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Physiologic stress, pain, agitation, and discomfort following arterial
switch operation

#### GUIDELINE CATEGORY

Evaluation\
Treatment

#### CLINICAL SPECIALTY

Anesthesiology\
Cardiology\
Critical Care\
Pediatrics\
Surgery

#### INTENDED USERS

Advanced Practice Nurses\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide a clinical guideline for anesthesia, analgesia, and sedation
following arterial switch operation

#### TARGET POPULATION

These guidelines are intended primarily for use in neonates (age
[\<]{.underline}30 days) who have undergone an arterial switch operation
(with or without ventricular septal defect closure).

The guidelines do [not]{.underline} address all considerations needed to
manage those with the following:

-   Adverse/allergic reaction to morphine, fentanyl, lorazepam, or
    midazolam

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Assessment**

1.  Assessment of hemodynamic stability as indicated by
    electrocardiographic monitoring, the mean arterial pressure (via
    arterial line), left atrial pressure (via transthoracic catheter),
    and urine output

2.  Assessment of pain relief, patient comfort, and level of sedation,
    as indicated by behavioral assessment and absence of tachycardia or
    hypertension

**Treatment**

1.  Fentanyl infusion

2.  Concurrent use of midazolam or lorazepam with the fentanyl infusion
    to ensure adequate sedation

3.  Provision of adequate analgesia and sedation using as needed doses
    of morphine and midazolam once the fentanyl infusion has been
    discontinued

#### MAJOR OUTCOMES CONSIDERED

-   Physiologic stress response to cardiac surgery

-   Pain control

-   Sedation

-   Risk for adverse hemodynamic events

-   Adverse effects of narcotics, such as respiratory depression

-   Time to extubation

-   Hemodynamic stability

-   Length of stay in the Cardiac Intensive Care Unit (CICU)

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

To select evidence for critical appraisal by the group for the update of
this guideline, the Medline, EmBase and the Cochrane databases were
searched. Evidence from 2000 and before was verified for inclusion in
the guidelines. Evidence from 2001 to January, 2006 was reviewed for
relevance to the clinical topics/questions to generate an unrefined,
\"combined evidence\" database using a search strategy focused on
answering clinical questions relevant to anesthesia, analgesia, or
sedation following arterial switch operations and employing a
combination of Boolean searching on human-indexed thesaurus terms (MeSH
headings using an OVID Medline interface) and \"natural language\"
searching on searching on human-indexed thesaurus terms (MeSH headings
using an OVID Medline interface) and \"natural language\" searching on
words in the title, abstract, and indexing terms. The citations were
reduced by: eliminating duplicates, review articles, non-English
articles, and adult articles. The resulting abstracts were reviewed by a
methodologist to eliminate low quality and irrelevant citations. During
the course of the guideline development, additional clinical questions
were generated and subjected to the search process, and some relevant
review articles were identified. April, 2000 was the last date for which
literature was reviewed for the previous version of this guideline. The
details of that review strategy are not documented. However, all
previous citations were reviewed for appropriateness to this revision.

A search using the above criteria was conducted for dates of January,
2006 through July, 2006. No relevant articles were found that would
require changes to the January, 2006 version of the recommendations.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The recommendations contained in this guideline were formulated by an
interdisciplinary working group which performed systematic and critical
literature reviews, using a grading scale, and examined current local
clinical practices.

Recommendations have been formulated by a consensus process directed by
best evidence, patient and family preference and clinical expertise.
During formulation of these guidelines, the team members have remained
cognizant of controversies and disagreements over the management of
these patients. They have tried to resolve controversial issues by
consensus where possible and, when not possible, to offer optional
approaches to care in the form of information that includes best
supporting evidence of efficacy for alternative choices.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Experience with the implementation of earlier publications of this
guideline has provided information which has been incorporated into this
revision.

The guidelines have been reviewed by clinical experts not involved in
the development process, senior management, and other individuals as
appropriate to their intended purposes. The guideline is based in part
on three independent reviews performed by members of Evidence-Based Care
Group of Health Policy & Clinical Effectiveness at Cincinnati
Children\'s Hospital and Medical Center (CCHMC) using AGREE criteria
(Appraisal of Guidelines for Research and Evaluation).

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Each recommendation is followed by evidence grades identifying the type
of supporting evidence. Definitions of the evidence grades are presented
at the end of the \"Major Recommendations\" field.

**Clinical Assessments**

1.  It is recommended that hemodynamic stability be maintained as
    indicated by mean arterial pressure \>45, left atrial pressure \<15,
    and urine output \>1cc/kg/hr. Physical exam should indicate adequate
    perfusion.

> **Note 1**: Continuous monitoring of electrocardiogram (ECG) and
> arterial blood pressure via an arterial line is recommended (Local
> Expert Consensus \[E\]).
>
> **Note 2**: Continuous monitoring of left atrial pressure with a
> transthoracic catheter is recommended (Local Expert Consensus \[E\]).

2.  It is recommended that adequate pain relief is provided as indicated
    by behavioral assessment and the absence of otherwise unexplained
    tachycardia or hypertension.

3.  It is recommended that patient comfort and sedation be maintained as
    indicated by behavioral assessment. The patient should not be at
    risk for inadvertent self-removal of lines and/or tubes.

**Treatment Recommendations**

4.  It is recommended that a fentanyl infusion at 10 micrograms/kg/hr be
    started on all post-operative arterial switch patients and
    maintained for at least 6 hours. The infusion should be discontinued
    if the patient has had no signs or symptoms of low cardiac output
    (mean arterial pressure \<45, urine output \<1 cc/kg/hr, persistent
    base deficit \>-4 despite correction with sodium bicarbonate
    \[NaHCO~3~\] or increase in lactate level \>0.5 mg/dl/hr) and is
    therefore considered a good candidate for extubation in the next 24
    hours.

> **Note 1**: A continuous infusion of high-dose fentanyl is maintained
> to blunt the physiologic stress response that occurs as a consequence
> of cardiac surgery (Anand, Hansen, & Hickey, 1990 \[D\]; Anand &
> Hickey, 1992 \[B\]). Because cardiac output decreases for at least the
> first 6 hours following cardiopulmonary bypass, it is recommended that
> the infusion be continued for at least this length of time (Wernovsky
> et al., 1995 \[A\]).
>
> **Note 2**: Because of the redistribution of fentanyl into lipid
> tissue, long-term infusion may result in prolongation of side effects
> such as apnea well beyond termination of the infusion (Cincinnati
> Children\'s Hospital Medical Center Formulary, 2006)\[X\]. Therefore,
> once pain management, rather than hemodynamic stability, becomes the
> primary reason for narcotic use, it is desirable to use bolus dosing
> of a less lipophilic agent such as morphine and to discontinue the
> fentanyl infusion (Local Expert Consensus \[E\]).
>
> **Note 3**: Ongoing metabolic acidosis caused by the continued
> production of lactic acid has been associated with a poor outcome
> following cardiac surgery in infants and children. (Charpie et al.,
> 2000 \[C\]; Munoz et al., 2000 \[C\]).

5.  It is recommended that midazolam (0.1 mg/kg/dose every 1 to 2 hours)
    or lorazepam (0.1 mg/kg/dose every 6 to 8 hours) be given
    concurrently with the fentanyl infusion to ensure adequate sedation
    in addition to anesthesia/analgesia.

> **Note**: Because of the variability in neonatal response to fentanyl
> and because of rapid development of tolerance to its sedative effects
> (in contrast to respiratory depressant effects), additional use of
> benzodiazepines is often necessary to maintain adequate sedation
> (Arnold et al., 1991 \[C\]).

6.  It is recommended that adequate analgesia and sedation be provided
    using as needed doses of morphine (0.1 mg/kg/dose) and midazolam
    (0.1 mg/kg/dose) once the fentanyl infusion has been discontinued.

> **Note**: The longer half-life of morphine makes it a better choice
> for intermittent dosing than fentanyl. The histamine release
> associated with morphine should be well tolerated hemodynamically by
> patients who are otherwise stable 6 hours after cardiopulmonary bypass
> (Saarenmaa et al., 1999 \[A\]; Saarenmaa, Neuvonen, & Fellman, 2000
> \[C\]; Santeiro et al., 1997 \[C\]; Hamon et al., 1996 \[C\]; Katz &
> Kelly, 1993 \[C\]; Arnold et al., 1991 \[C\]; Murat et al., 1988
> \[C\]).

**Definitions**:

**Evidence Based Grading Scale**

M: Meta-analysis or systematic review\
A: Randomized controlled trial: large sample\
B: Randomized controlled trial: small sample\
C: Prospective trial or large case series\
D: Retrospective analysis\
S: Review article\
O: Other evidence\
E: Expert opinion or consensus\
F: Basic laboratory research\
L: Legal requirement\
Q: Decision analysis\
X: No evidence

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=9865)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence is identified and classified for each
recommendation (see \"Major Recommendations\") using the following
scheme:

M: Meta-analysis or systematic review\
A: Randomized controlled trial: large sample\
B: Randomized controlled trial: small sample\
C: Prospective trial or large case series\
D: Retrospective analysis\
S: Review article\
O: Other evidence\
E: Expert opinion or consensus\
F: Basic laboratory research\
L: Legal requirement\
Q: Decision analysis\
X: No evidence

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Blunting of physiologic stress response to cardiac surgery

-   Pain control

-   Sedation that provides comfort and safety

-   Decreased risk for adverse hemodynamic events

#### POTENTIAL HARMS

-   Respiratory depression associated with high-dose narcotic use

-   Because of the redistribution of fentanyl into lipid tissue,
    long-term infusion may result in prolongation of side effects such
    as apnea well beyond termination of the infusion.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   In developing this guideline, the working group recognizes the
    paucity of large-scale studies with direct bearing on this
    particular focus population. The specific recommendations in this
    guideline are drawn from directly applicable studies where possible,
    but are largely extrapolated from smaller studies and from studies
    more indirectly related to the present issues.

-   These recommendations result from review of literature and practices
    current at the time of their formulations. This protocol does not
    preclude using care modalities proven efficacious in studies
    published subsequent to the current revision of this document. This
    document is not intended to impose standards of care preventing
    selective variances from the guidelines to meet the specific and
    unique requirements of individual patients. Adherence to this
    pathway is voluntary. The physician in light of the individual
    circumstances presented by the patient must make the ultimate
    judgment regarding the priority of any specific procedure.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

Appropriate companion documents have been developed to assist in the
effective dissemination and implementation of the guideline.

#### IMPLEMENTATION TOOLS

Foreign Language Translations\
Patient Resources

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Cincinnati Children\'s Hospital Medical Center. Evidence based care
guideline for anesthesia, analgesia and sedation following arterial
switch operation. Cincinnati (OH): Cincinnati Children\'s Hospital
Medical Center; 2006 Jan 10. 8 p. \[16 references\]

#### ADAPTATION

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

#### DATE RELEASED

2001 Jan 22 (revised 2006 Jan 1)

#### GUIDELINE DEVELOPER(S)

Cincinnati Children\'s Hospital Medical Center - Hospital/Medical Center

#### SOURCE(S) OF FUNDING

Cincinnati Children\'s Hospital Medical Center

#### GUIDELINE COMMITTEE

Cardiac Guideline Development Team 2006

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Cincinnati Children\'s Hospital Medical Center Physicians*: Peter
Manning , MD, Cardiac Surgery; Catherine Dent, MD, Cardiac Intensive
Care; William Border, MD, Cardiology; James Spaeth MD, Anesthesia;
Michael Alice Moga, MD, Cardiology/Fellow

*Patient Services*: Karen Uzark, PhD, CPNP, Cardiology; Susan Ryckman,
MS, CPNP, Cardiac Services; Betsy Adler, MS, PNP, Cardiac Surgery;
Melissa Magness, RN, Cardiac ICU; Tammy Lingsch, RN, A6 Central; Cynthia
Wedekind, Pharm D, Clinical Pharmacy; Jenni Raake, RRT, Respiratory
Care; Shawna Kirkendall, RN, Manager, A 6 Central

*Division of Health Policy & Clinical Effectiveness Support*: Eloise
Clark, MPH; Danette Stanko, MA, MPH, Epidemiologist; Kate Rich, Lead
Decision Support Analyst; Carol Frese, RN, Medical Reviewer; Eduardo
Mendez, RN, MPH, Dir. Evidence-Based Care; Edward Donovan, MD, Medical
Director, Clinical Effectiveness

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

This guideline was developed without external funding.

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Cincinnati Children\'s
Hospital Medical Center. Evidence based clinical practice guideline for
anesthesia, analgesia and sedation following arterial switch operation.
Cincinnati (OH): Cincinnati Children\'s Hospital Medical Center; 2001
Jan 22. 8 p.

Once the guideline has been in place for four years, the development
team reconvenes to explore the continued validity of the guideline. This
phase can be initiated at any point that evidence indicates a critical
change is needed.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[Cincinnati Children\'s Hospital Medical Center Web
site](http://www.cincinnatichildrens.org/svc/alpha/h/health-policy/ev-based/default.htm).

For information regarding the full-text guideline, print copies, or
evidence based practice support services contact the Children\'s
Hospital Medical Center Health Policy and Clinical Effectiveness
Department at <HPCEInfo@chmcc.org>.

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

The following is available:

-   Going home after heart surgery. Home care. Cincinnati (OH):
    Cincinnati Children\'s Hospital Medical Center; 2004 Dec. 1 p.
    Available in English and Spanish from the [Cincinnati Children\'s
    Hospital Medical Center Web
    site](http://www.cincinnatichildrens.org/health/info/heart/home/after-heart-surgery.htm).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on March 11, 2004. This NGC
summary was updated by ECRI on November 29, 2006. The updated
information was verified by the guideline developer on December 19,
2006.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

Copies of [Cincinnati Children\'s Hospital Medical Center
(CCHMC)](http://www.cincinnatichildrens.org/svc/alpha/h/health-policy/ev-based/default.htm)
Evidence-Based Clinical Practice Guidelines (EBCG) are available online
and may be distributed by any organization for the global purpose of
improving child health outcomes. Examples of approved uses of CCHMC´s
EBCG include the following:

-   Copies may be provided to anyone involved in the organization\'s
    process for developing and implementing evidence-based care
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-   Hyperlinks to the CCHMC website may be placed on the organization\'s
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-   The EBCG may be adopted or adapted for use within the organization,
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-   Copies may be provided to patients and the clinicians who manage
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Notification of CCHMC at <HPCEInfo@cchmc.org> for any EBCG adopted,
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Date Modified: 11/3/2008