Intranasal Midazolam in Children as a Pre-Operative Sedative

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline Placebo

Control patients will receive intranasal saline

Group Type PLACEBO_COMPARATOR

saline placebo

Intervention Type DRUG

intranasal saline given as placebo

Nasal Midazolam Only

Patients will receive 0.2 mg/kg of intranasal midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

midazolam 0.2 mg/kg given intranasally

Midazolam Plus 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.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

midazolam 0.2 mg/kg given intranasally

xylocaine

Intervention Type DRUG

intransal xylocaine given in conjunction with intranasal midazolam

Interventions

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Midazolam

midazolam 0.2 mg/kg given intranasally

Intervention Type DRUG

xylocaine

intransal xylocaine given in conjunction with intranasal midazolam

Intervention Type DRUG

saline placebo

intranasal saline given as placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No