Trial | NCT03725995  Report issue

Title

Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children
The Effectiveness of Topical Lidocaine in Relieving Pain Related To Intranasal Midazolam Sedation: A Randomized, Placebo-Controlled Clinical Trial

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    63
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.
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.
Study Started
Jun 01
2017
Primary Completion
Jan 01
2018
Study Completion
Oct 10
2018
Last Update
Nov 05
2018

Drug 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.

  • Other names: A

Drug Lidocaine-Midazolam [lidocaine (xylocaine), midazolam (versed)]

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.

  • Other names: B

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.

  • Other names: C

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.

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.

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.

Criteria 

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 Criteria:

known allergy to midazolam or any other benzodiazepines.
upper respiratory tract infection with nasal discharge.
No Results Posted