Definitions for the strength of evidence (Class I-III) and strength of recommendations (Level A-C) are repeated at the end of the "Major Recommendations" field.
- Should pediatric patients undergo a period of preprocedural fasting to decrease the incidence of clinically important complications during procedural sedation in the emergency department (ED)?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. Procedural sedation may be safely administered to pediatric patients in the ED who have had recent oral intake.
Level C recommendations. None specified.
- Is nitrous oxide effective and safe for providing pediatric procedural sedation in the ED?
Note: A previous clinical policy focused on the efficacy and safety of etomidate, fentanyl/midazolam, ketamine, methohexital, pentobarbital, and propofol for achieving sedation and analgesia in pediatric patients undergoing procedures in the ED. See Appendix C in the original guideline document for the recommendations from the previous clinical policy.
Patient Management Recommendations for Nitrous Oxide
Level A recommendations. Nitrous oxide at 50% concentration can be used with concurrent local anesthesia for safe and effective procedural sedation in healthy children undergoing painful procedures.
Level B recommendations. A gas scavenging system should be used for protection of health care providers when administering nitrous oxide.
Level C recommendations
- Nitrous oxide at 60% to 70% concentration may be used with concurrent local anesthesia for safe and effective procedural sedation in healthy children undergoing painful procedures.
- Nitrous oxide may be combined with other sedative analgesic agents to augment sedation, but patients receiving these combinations should be carefully monitored for deepening sedation, respiratory depression, and other adverse events.
- Nitrous oxide may be less effective in reducing procedure-related distress in younger children compared with older children.
- Nurses trained in principles of nitrous oxide sedation, including the specific nitrous oxide administration device, may safely administer nitrous oxide to healthy children while under the supervision of an emergency physician or other appropriately trained and credentialed specialist in the ED.
- Can oral sucrose be used to reduce infant distress due to minor, painful procedures in the ED?
Patient Management Recommendations
Level A recommendations. Oral sucrose can be used to reduce signs of distress due to minor, painful procedures in preterm and term neonates (less than 28 days old).
Level B recommendations
- Effective doses for neonates range from 0.1 mL of 24% to 2 mL of 50% sucrose (with the most commonly studied dose being 2 mL of 24% sucrose).
- Oral sucrose can be used in combination with sucking (i.e., a pacifier) to improve its efficacy.
- Oral sucrose may be safely administered to full-term neonates and infants.
Level C recommendations
- Sucrose appears to be less effective in infants between 1 month and 6 months of age.
- Effective doses for infants between 1 month and 6 months of age may range from 0.75 mL of 50% to 2 mL of 75% sucrose.
- Effective doses for very-low-birth-weight, preterm infants may be as low as 0.05 mL of 24% sucrose.
- Oral sucrose should be given approximately 2 minutes before an invasive procedure.
- Oral sucrose may be safely given to low-birth-weight, preterm neonates.
- Is chloral hydrate effective and safe for providing procedural sedation in children in the ED?
Note: This critical question about chloral hydrate was included for completeness because of its use in some practice settings. A previous clinical policy focused on the efficacy and safety of etomidate, fentanyl/midazolam, ketamine, methohexital, pentobarbital, and propofol for achieving sedation and analgesia in pediatric patients undergoing procedures in the ED. These recommendations about the safety and efficacy of chloral hydrate do not imply superiority to the above medications. See Appendix C of the original guideline document for the recommendations from the previous clinical policy.
Patient Management Recommendations for Chloral Hydrate
Level A recommendations
- Chloral hydrate may be used to provide effective procedural sedation in pediatric patients undergoing painless diagnostic studies. However, children receiving chloral hydrate should be properly monitored and managed by appropriately trained personnel due to the risk of respiratory depression and hypoxia.
- Chloral hydrate should not be considered a first-line agent in children older than 48 months because of decreased efficacy as compared with younger children.
Level B recommendations. None specified.
Level C recommendations
- Chloral hydrate has the potential for resedation and may produce residual effects up to 24 hours after administration.
- Chloral hydrate may be used safely and effectively in properly monitored children who have congenital cardiac anomalies and are undergoing painless diagnostic procedures.
- Chloral hydrate should not be used in children with neurodevelopmental disorders due to an increased incidence of adverse effects and decreased efficacy as compared with healthy children.
- Pediatric patients receiving chloral hydrate should not be intentionally fasted because of increased procedural sedation failure rates.
- What clinical indicators support safe discharge after pediatric procedural sedation in the ED?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations. No universally applicable, evidence-based set of clinical indicators has been established. Emergency physicians, in conjunction with their institutions, should develop criteria for safe discharge.
Definitions
Strength of Evidence
Literature Classification Schema^
Design/
Class |
Therapy* |
Diagnosis** |
Prognosis*** |
| 1 |
Randomized, controlled trial or meta-analyses of randomized trials |
Prospective cohort using a criterion standard |
Population prospective cohort |
| 2 |
Nonrandomized trial |
Retrospective observational |
Retrospective cohort
Case control
|
| 3 |
Case series
Case report
Other (e.g., consensus, review)
|
Case series
Case report
Other (e.g., consensus, review)
|
Case series
Case report
Other (e.g., consensus, review)
|
^ Some designs (e.g., surveys) will not fit this schema and should be assessed individually.
*Objective is to measure therapeutic efficacy comparing >2 interventions.
**Objective is to determine the sensitivity and specificity of diagnostic tests.
*** Objective is to predict outcome including mortality and morbidity.
Approach to Downgrading Strength of Evidence*
| |
Design/Class |
| Downgrading |
1 |
2 |
3 |
| None |
I |
II |
III |
| 1 level |
II |
III |
X |
| 2 levels |
III |
X |
X |
| Fatally flawed |
X |
X |
X |
*See "Description of Methods Used to Analyze the Evidence" field for more information.
Strength of Recommendations
Level A recommendations. Generally accepted principles for patient management that reflect a high degree of clinical certainty (i.e., based on strength of evidence Class I or overwhelming evidence from strength of evidence Class II studies that directly address all of the issues)
Level B recommendations. Recommendations for patient management that may identify a particular strategy or range of management strategies that reflect moderate clinical certainty (i.e., based on strength of evidence Class II studies that directly address the issue, decision analysis that directly addresses the issue, or strong consensus of strength of evidence Class III studies)
Level C recommendations. Other strategies for patient management that are based on preliminary, inconclusive, or conflicting evidence, or, in the absence of any published literature, based on panel consensus
There are certain circumstances in which the recommendations stemming from a body of evidence should not be rated as highly as the individual studies on which they are based. Factors such as heterogeneity of results, uncertainty about effect magnitude and consequences, strength of prior beliefs, and publication bias, among others, might lead to such a downgrading of recommendations.
