• 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]

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.

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

Evaluation
Treatment

Anesthesiology
Cardiology
Critical Care
Pediatrics
Surgery

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

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

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

The guidelines do not address all considerations needed to manage those with the following:

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

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

• 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)

Searches of Electronic Databases

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.

Not stated

Not stated

Not applicable

Systematic Review

Not stated

Expert Consensus

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.

Not applicable

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

Internal Peer Review

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).

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 [NaHCO₃] 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

None provided

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

• Blunting of physiologic stress response to cardiac surgery
• Pain control
• Sedation that provides comfort and safety
• Decreased risk for adverse hemodynamic events

• 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.

• 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.

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

Getting Better

Effectiveness
Patient-centeredness

• 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]

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

2001 Jan 22 (revised 2006 Jan 1)

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

Cincinnati Children's Hospital Medical Center

Cardiac Guideline Development Team 2006

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

This guideline was developed without external funding.

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.

None available

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.