Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-10-10

Brief Summary

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Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.

Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.

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Detailed Description

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Background and Aims: The use of intranasal midazolam (INM) has been commonly associated with a burning sensation of the nasal mucosa. However, despite its significance, this subject has received little adequate research focus. The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.

Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug nasally via a pre-calibrated spray as per the following assignments:

A: received 0.5 mg/kg midazolam, B: received lidocaine 2% prior to 0.5 mg/kg midazolam.

C: received saline 9% (placebo), 0.5mg/kg. Children were asked to record the degree of pain using Wong-Baker-Faces- (WBFS) Scale.

Conditions

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Burning Nose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

blinded, randomized placebo-controlled trial, comparing three groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The participant was blinded, the first assistant who explained the pain scale to the participants and asked him\\her to record the score of pain associated with the drug administration was also blinded.

Study Groups

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A (Midazolam)

21 children received 0.5 mg/kg intranasal medication (midazolam), with a maximum dose of 10 mg, via a spray of 0.2 ml per puff, administering the drug was alternated between the two nostrils of the child.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Patients received 0.5 mg/kg midazolam, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.

B (Lidocaine-Midazolam)

21 children received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg intranasal medication (midazolam),administering the drug was alternated between the two nostrils of the child, with a maximum dose of 10 mg via a spray of 0.2 ml per puff.

Group Type EXPERIMENTAL

Lidocaine-Midazolam

Intervention Type DRUG

Patients received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg midazolam, with a maximum dose of 10 mg. , Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.

C (Placebo)

21 children received intranasal medication (saline 9% as placebo), 0.5 mg/kg, with a maximum dose of 10 mg via a spray of 0.2 ml per puff,administering the drug was alternated between the two nostrils of the child.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients received saline 9% (placebo), 0.5 mg/kg, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.

Interventions

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Midazolam

Patients received 0.5 mg/kg midazolam, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.

Intervention Type DRUG

Lidocaine-Midazolam

Patients received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg midazolam, with a maximum dose of 10 mg. , Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.

Intervention Type DRUG

Placebo

Patients received saline 9% (placebo), 0.5 mg/kg, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.

Intervention Type DRUG

Other Intervention Names

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A B C

Eligibility Criteria

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Inclusion Criteria

* uncooperative children scored 1 or 2 on Frankle Scale.
* had no medical history of neurological or cognitive alterations.
* No facial deformities.
* ASA Classification I.
* requiring dental treatment under local anesthesia.