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

Jennifer Victory, RN, CCRC

Status and phase: Completed; Phase 4

Conditions: Sedation

Treatments: Drug: Midazolam; Drug: xylocaine; Drug: saline placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02356705

1098

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18 months to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. ASA Class 3 or greater
2. History of allergy to midazolam or xylocaine
3. Presence of acute respiratory infection at time of surgery
4. Parent unwilling or unable to provide informed consent
5. Parent unwilling or unable to complete the OBD VAS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 3 patient groups, including a placebo group

Saline Placebo

Placebo Comparator group

Description:

Control patients will receive intranasal saline

Treatment:

Drug: saline placebo

Nasal Midazolam Only

Active Comparator group

Description:

Patients will receive 0.2 mg/kg of intranasal midazolam

Treatment:

Drug: Midazolam

Midazolam Plus Xylocaine

Active Comparator group

Description:

Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.

Treatment:

Drug: Midazolam

Drug: xylocaine