Midazolam is a benzodiazepine that produces sedation, amnesia, and relief of anxiety. It has become a commonly used agent for conscious sedation of children before diagnostic or therapeutic procedures or before induction of anesthesia. Until recently, only the intravenous form of the drug was available. Many practitioners used the IV preparation for oral administration to avoid the additional trauma of starting an IV in the child. However, the liquid was very bitter even with added flavoring.
In November 1998, the Food and Drug Administration approved Versed Syrup, a clear, purplish-red, cherry flavored liquid that contains an artificial bitterness modifier. The reported acceptance rate by children was 90% (Personal communication, 1999). The syrup contains 2 mg midazolam per 1 ml. The recommended dose for children is a single dose of 0.25 to 0.5 mg/kg to a maximum dose of 20 mg. Younger children (6 months to less than 6 years of age) and less cooperative children may require a higher dose of up to 1 mg/kg. In obese children, the dose should be calculated based on ideal body weight. The dose should be individualized for the patient's age, level of anxiety, and medical need. The time to onset is usually within 10 to 20 minutes.
Versed Syrup is supplied in an amber glass bottle of 118 mL of syrup with 1 press-in bottle adapter, 4 single-use, graduated, oral dispensers, and 4 tip caps. The syrup should not be mixed with any liquid, especially grapefruit juice. Flavonoids in grapefruit juice can increase the bioavailability of certain drugs by inhibition of cytochrome P450 3A4 isozyme found in the liver and intestinal wall. Thus, the potential for increased drug activity and adverse effects exists (Lillery and Guanci, 1998).
The most serious side effect of midazolam is respiratory depression or arrest. The reversal agent, flumazenil (Romazicon) should be available for emergency use. Flumazenil is not approved for use in children. However, pediatric dosing experience suggests 0.01 mg/kg (0.1 ml/kg) as loading dose followed by 0.005 mg/kg/min (0.05 ml/kg/min) until awake or to a maximum of 1 mg (10 ml) (Jones and others, 1991). The recommended initial dose for children 20 kg or more is 0.2 mg (2ml) IV over 15 seconds. If there is no response after 45 seconds, the dose is repeated as needed at 60-second intervals for maximum dose of 1 mg (10 ml).
The use of other sedating drugs, such as opioids, increases the risk of respiratory depression, and the reversal agent naloxone (Narcan) should be readily available. The recommended dose is 0.5 mcg/kg for children up to 40 kg. (American Pain Society, 1992). This small dose effectively reverses respiratory depression without reversing analgesia. Since naloxone's duration of action is only about 45 minutes, additional doses of Narcan may be needed.
Some practitioners use only Versed for sedation during painful procedures to avoid the opioid's additional depressant effect on respirations. Others believe that Versed is sufficient because its amnestic effect prevents the child's memory of the pain. Adequate research data on the duration and extent of amnesia in children does not exist to support this rationale. Also the argument can be made that opioids should be used without midazolam to reduce the additional respiratory risk because they provide analgesia and sedation. Since both midazolam and opioids have reversal agents, both are recommended for conscious sedation during painful procedures.
Nurses should encourage the use of Versed Syrup rather than the use of the IV form because of its greater acceptability. The cost of both preparations is about the same, but much time is saved in administering the syrup to a more cooperative child.
See also Pediatric Conscious Sedation.
American Pain Society: Principles of analgesic use in the treatment of acute pain and chronic cancer pain, ed 3, Skokie, IL, 1992.
Jones RDM and others: Antagonism of the hypnotic effect of midazolam in children: a randomized double-blind study of placebo and flumazenil administered after midazolam-induced anesthesia, Br J Anaesth 66:660-666, 1991.
Lillery LL and Guanci R: Grapefruit and medication, Am J Nurs 98(12):10, 1998.
Personal Communication, Anne L. Lear, Medical Center Representative, Indianapolis, IN, Roche Laboratories, February 1, 1999.
* Information from package insert, Versed (Midazolam HCI) Syrup, Roche Laboratories, N J, 1998.
March 15, 2002
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