Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

Phase 4

Completed

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia
American Society of Anesthesiologists (ASA) Class 1 or 2
Parent willing and able to provide written informed consent
Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Saline Placebo	saline placebo	Control patients will receive intranasal saline
Nasal Midazolam Only	Midazolam	Patients will receive 0.2 mg/kg of intranasal midazolam
Midazolam Plus Xylocaine	Midazolam	Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.
Midazolam Plus Xylocaine	xylocaine	Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.

Primary Outcome Measures

Name	Time	Method
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement	25 minutes	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)

Secondary Outcome Measures

Name	Time	Method
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room	20 minutes	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)