Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children

Burning Nose Clinical Trial

— INM  

Official title:

The Effectiveness of Topical Lidocaine in Relieving Pain Related To Intranasal Midazolam Sedation: A Randomized, Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725995
• Other study ID #: Tishreen U- PediatricDentistry
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2017
• Est. completion date: October 10, 2018

Study information

• Verified date: November 2018
• Source: Tishreen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 10, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burning Nose
• Burns

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Tishreen University	Latakia

Sponsors (1)

Lead Sponsor	Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & 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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.