Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children

NCT03725995 | Completed Phase 2 DMC

• 1 other identifier: Tishreen U- PediatricDentistry
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burning Nose

Keywords

midazolam; Lidocaine; Intranasal; Burning; Children

Outcome Measures

Primary Outcomes (1)

• Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine .

  The use of intranasal midazolam is associated with a burning sensation of the nasal mucosa, the pain was assessed using a self report pain scale Wong Baker Faces Scale, the degree of pain is determined by choosing a score of (0-2-4-6-8-10) (minimum score 0, means no pain, maximum score 10, means the drug hurts worst, higher scores are worse) the scores were reported by children received intranasal midazolam alone, intranasal midazolam preceded by intranasal lidocaine or intranasal saline (placebo).

  one to five minutes following the administration.

Study Arms (3)

A (Midazolam)

ACTIVE COMPARATOR

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.

Drug: Midazolam

B (Lidocaine-Midazolam)

EXPERIMENTAL

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.

Drug: Lidocaine-Midazolam

C (Placebo)

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Midazolam 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.

Also known as: A

A (Midazolam)

Lidocaine-Midazolam 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.

Also known as: B

B (Lidocaine-Midazolam)

Placebo 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.

Also known as: C

C (Placebo)

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• known allergy to midazolam or any other benzodiazepines.
• upper respiratory tract infection with nasal discharge.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University

Latakia, Syria

Location

Related Publications (1)

• Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.

  PMID: 27739142 RESULT

MeSH Terms

Conditions

Paresthesia

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nabih Raslan, Dr.

  Tishreen University

  STUDY CHAIR

• Walaa Khalil, Dr.

  Tishreen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: blinded, randomized placebo-controlled trial, comparing three groups.

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 31, 2018
• Study Start: June 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: October 10, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

SY (1)