Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
midazolam 0.2 mg/kg given intranasally
intransal xylocaine given in conjunction with intranasal midazolam
intranasal saline given as placebo
Bassett Healthcare Network
Cooperstown, New York, United States
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement
Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement * 1\. Agitated: Previous criteria and/or refuses mask. (worst score) * 2\. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. * 3\. Calm: Previous criteria and accepts mask. * 4\. Drowsy: Previous criteria and accepts mask. * 5\. Asleep: Previous criteria and accepts mask. (best score)
Time frame: 25 minutes
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room
Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia * 1\. Agitated: Patient clinging to parents and/or crying (worst score) * 2\. Alert: Patient is aware but not clinging to parent, may whimper but not cry. * 3\. Calm: Sitting or lying comfortably with spontaneous eye opening. * 4\. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation. * 5\. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score)
Time frame: 20 minutes
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