Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children

Last updated: November 2, 2018
Sponsor: Tishreen University
Overall Status: Completed

Phase

2/3

Condition

Hyponatremia

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT03725995
Tishreen U- PediatricDentistry
  • Ages 4-11
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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.

Exclusion

Exclusion Criteria:

  • known allergy to midazolam or any other benzodiazepines.

  • upper respiratory tract infection with nasal discharge.

Study Design

Total Participants: 63
Study Start date:
June 01, 2017
Estimated Completion Date:
October 10, 2018

Study Description

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.

Connect with a study center

  • Tishreen University

    Latakia,
    Syrian Arab Republic

    Site Not Available

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