Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT02679781
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.6
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure:

1. acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation	Drug: oral midazolam; Drug: nasal midazolam	N/A

Detailed Description

• Prospective, parallel design

• Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 =

75% airway obstruction), upper respiratory tract infection or nasal discharge.

• Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam;

• Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

• Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered).

• Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care
• Actual Study Start Date: Mar 28, 2017
• Actual Primary Completion Date: Dec 15, 2020
• Actual Study Completion Date: Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oral sedation administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.	Drug: oral midazolam; administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.; Other Names: oral dormicum
Active Comparator: nasal sedation administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.	Drug: nasal midazolam; administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.; Other Names: nasal dormicum

Outcome Measures

Primary Outcome Measures

1. Number of Participants Compliant With Oral or Nasal Midazolam Administration [the compliance in taking the medication will be assessed at the time of administration and recorded immediately.]

   the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered).

Secondary Outcome Measures

1. Behavior During Dental Treatment [the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes.]

   the effect of oral or nasal midazolam on behaviour will be assessed by blind observer using Houpt scale. Houpt scale measures behavior by rating overall behavior. the scale is 1 to 6, higher score mean a better behavior. = Aborted, no treatment rendered. = Poor, treatment interrupted, only partial treatment was completed 3= Fair, treatment interrupted but eventually completed 4= Good, difficult but all treatment was performed 5= Very good, some limited crying or movement 6= Excellent, no crying or movement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments.

Exclusion Criteria:

• enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 =

75% airway obstruction), upper respiratory tract infection or nasal discharge.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 31, 2016

More Information

Publications

None provided.

• Responsible Party: Avia Fux, pediatric dentist, Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT02679781
• Other Study ID Numbers: 0678-15-HMO-CTIL
• First Posted: Feb 10, 2016
• Last Update Posted: Jan 14, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Midazolam

Study Results

Participant Flow

Arm/Group Title	Oral Sedation	Nasal Sedation
Arm/Group Description	administration of 0.5mg/kg oral midazolam.	administration of 0.2mg/kg nasal midazolam.
Period Title: Overall Study
STARTED	37	33
COMPLETED	30	30
NOT COMPLETED	7	3

Baseline Characteristics

Arm/Group Title	Oral Sedation	Nasal Sedation	Total
Arm/Group Description	administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.	administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.25 (1.39)	4.46 (1.25)	4.36 (1.32)
Sex: Female, Male (Count of Participants)
Female	15 50%	14 46.7%	29 48.3%
Male	15 50%	16 53.3%	31 51.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Israel	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Compliant With Oral or Nasal Midazolam Administration
Description	the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered).
Time Frame	the compliance in taking the medication will be assessed at the time of administration and recorded immediately.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Sedation	Nasal Sedation
Arm/Group Description	administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.	administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Measure Participants	30	30
willingly	11 36.7%	4 13.3%
coaxed	14 46.7%	18 60%
forced	5 16.7%	8 26.7%

2. Secondary Outcome

Title	Behavior During Dental Treatment
Description	the effect of oral or nasal midazolam on behaviour will be assessed by blind observer using Houpt scale. Houpt scale measures behavior by rating overall behavior. the scale is 1 to 6, higher score mean a better behavior. = Aborted, no treatment rendered. = Poor, treatment interrupted, only partial treatment was completed 3= Fair, treatment interrupted but eventually completed 4= Good, difficult but all treatment was performed 5= Very good, some limited crying or movement 6= Excellent, no crying or movement
Time Frame	the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Sedation	Nasal Sedation
Arm/Group Description	administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.	administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Measure Participants	30	30
Mean (Standard Deviation) [score on a scale]	5.17 (0.79)	4.80 (0.80)

Adverse Events

Time Frame	From administering the medication until recovery from sedation- at least 2 hours for each patient
Arm/Group Title	Oral Sedation		Nasal Sedation
Arm/Group Description	administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.		administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
All Cause Mortality
	Oral Sedation		Nasal Sedation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/33 (0%)
Serious Adverse Events
	Oral Sedation		Nasal Sedation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Oral Sedation		Nasal Sedation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.