Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-07-02 @ 6:16 PM
Study NCT ID:
NCT03725995
Status:
COMPLETED
Last Update Posted:
2018-11-05
First Post:
2018-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children
Sponsor:
Tishreen University
Organization:
Study Overview
Official Title:
The Effectiveness of Topical Lidocaine in Relieving Pain Related To Intranasal Midazolam Sedation: A Randomized, Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INM
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.
Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.
Detailed 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: