Medications

• Initial dose: 25-50mg up to100mg if required
• Onset of action: 2-3 minutes
• Peak effect: 60-90 minutes
• Duration of effect: More than 240 minutes
• Anticholinergic and sedative properties
• Pregnancy: B
• Lactation: Probably safe

Pediatric (children other than premature infants and neonates)

• One time dose: 1.25mg/kg

Reversal Agents:None

• One time dose: 12.5- 50mg
• Onset of action: 2-5 minutes
• Peak effect: Unknown
• Duration of effect: More than 120 minutes
• Pregnancy: -C
• Lactation-Possibly unsafe
• BLACK BOX WARNING: unsafe in children <2 years; use with caution in children >2 years due to respiratory depression; severe tissue injury if extravasation occurs

Pediatric

• 12.5-25 IV x 1 dose

Reversal Agents:None

• Initial dose: 1.25-2.5mg slow IV
• Additional doses: Additional 1.25mg doses may be administered to achieve the desired effect
• Onset of action: 3-10 minutes
• Peak effect: 30 minutes
• Duration of effect: 2-4 hours
• BLACK BOX WARNING: proarrhythmic effects
• Pregnancy: C
• Lactation: Safety unknown

Reversal Agents:None

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Pregnancy Considerations

• Smallest effective doses should be used
• Greatest risk is during first trimester
• Should also be avoided close to time of delivery
• FDA categorizes drug safety for pregnancy
• Consultation with obstetrician and/or anesthesiologist is recommended
• Meperidine alone is recommended
• Midazolam should be avoided

Safety in Pregnancy of Commonly Used Medications for Endoscopic Sedation

• Does not appear to be teratogenic in two major studies
• Preferred over fentanyl and morphine

FDA Category:C Comments:

• Appears to be safe in humans when given in low doses typical for endoscopy
• Not teratogenic but was embryocidal in rats
• Rapid onset of action and shorter recovery time than meperidine

FDA Category:B Comments:

• Does not appear to be teratogenic
• Contradicted in mothers who are dependent on opiates because it can precipitate opiate-withdrawal symptoms
• To be used only in cases of respiratory depression, hypotension, or unresponsiveness under close monitoring
• Risk of resedation as drug is metabolized

FDA Category:D
Comments:

• Diazepam should not be used for sedation in pregnant women
• Sustained use of diazepam in pregnancy has been linked to cleft palate and neurobehavioral disorders
• Midazolam has not been reported to be associated with congenital abnormalities
• Midazolam is the preferred benzodiazepine when meperidine is inadequate
• Midazolam use in the first trimester should be avoided

FDA Category:C
Comments:

• Little is known about safety profile
• Not teratogenic but produces neurobehavioral changes in male rats exposed in utero

FDA Category:B
Comments:

• Safety in first trimester has not been established
• When administered to a pregnant patient, it is recommended that this drug be administered by an anesthesiologist due to narrow therapeutic index and need for close monitoring

FDA Category:B
Comments:

• Not contraindicated in pregnancy

FDA Pregnancy Categories

The FDA-assigned pregnancy categories as used in the Drug Formulary are as follows:

Category A

• Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

• Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C

• Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

• There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

• Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Other Considerations

Pediatric Considerations:

• Anesthesia assistance is standard of care for sedating the pediatric populations

Elderly Considerations:

• Use fewer agents at lower doses with more time in between doses
• Choose agents that have a short half-life, minimal active metabolites and limited side effects

Obstructive Sleep Apnea Considerations:

• Sedation relaxes the muscle tone of the upper airway and increases airway resistance resulting in a reduction of the diameter of the airway

Sources

Cohen, L.B., DeLegge, M.H., Aisenberg, J. et al. (2007). AGA Institute Review of Endoscopic Sedation, Gastroenterology, 133:675-701.

Briggs, G.G., Greeman, R,K,, Yaffe, S.J (2011). Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. 9^th ed. Philadelphia: Lippincott Williams & Wilkins.

Kost, M. (2004). Moderate Sedation/Analgesia: Core Competencies for Practice, 2nd Ed. St. Louis, MO: Saunders. 116.

Ludwin, D.B., Shafer, S.L. (2008). CON: The black box warning on droperidol should not be removed (but should be clarified). Anesthesia & Analgesia.106:1418–20. Epocrates Online. Retrieved from: https://online.epocrates.com/noFrame/?ICID=eolepocratesheaderbutton

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