Burning Nose
Conditions
Keywords
midazolam, Lidocaine, Intranasal, Burning, Children
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.
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.
Interventions
DRUGMidazolam
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.
DRUGLidocaine-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.
DRUGPlacebo
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.
Sponsors
Tishreen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The participant was blinded, the first assistant who explained the pain scale to the participants and asked him\\her to record the score of pain associated with the drug administration was also blinded.
Intervention model description
blinded, randomized placebo-controlled trial, comparing three groups.
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine . | one to five minutes following the administration. | 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). |
Countries
Syria
Outcome results
None listed