Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children

Tishreen University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Burning Nose

Treatments: Drug: Lidocaine-Midazolam; Drug: Midazolam; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03725995

Tishreen U- PediatricDentistry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

63 participants in 3 patient groups, including a placebo group

A (Midazolam)

Active Comparator group

Description:

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.

Treatment:

Drug: Midazolam

B (Lidocaine-Midazolam)

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine-Midazolam

C (Placebo)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo