Effectiveness of two sedative drugs on pediatric patients during dental treatment

Not Applicable

Completed

• Conditions: Sedation of pediatric patients during dental treatment; Oral Health

• Registration Number: ISRCTN13661311
• Lead Sponsor: King Saud University

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35204863/ Post-discharge effects and parents' opinions (added 15/07/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-22
• Study Start: 2021-11-23
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. 3 - 6 years old
2. ASA I
3. Frankl behaviour rating scale 1 or 2
4. Mallampati score I or II
5. Brodsky tonsillar size scoring 0 or 1 or 2
6. Children within the normal range of weight
7. Children who needed two sedation visits for completion of dental treatment
8. Children who needed a comparable dental treatment (as regards restorations, pulp treatment, crowns, extraction) on both sides of the same jaw.

Exclusion Criteria

1. Children with learning difficulties or mental disabilities
2. Children with active upper respiratory tract infection, any history of a recent cough or cold (less than 2 weeks)
3. Children with a known allergy or hypersensitive reaction to either midazolam or fentanyl
4. Children at risk of airway obstruction
5. Children with any intranasal pathology or congenital anomaly
6. Children with a previous history of moderate sedation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The sedation scores were recorded using the Modified Observer’s Alertness/ Sedation Scale (MOAA/S) after sedation at each visit<br>2. The behavior scores were recorded using a four-point scale (4 = combative, disoriented, or excited; 3 = moderately agitated; 2 = not calm; and 1 = calm) after sedation at each visit<br>3. Post-discharge adverse effects and parental satisfaction and preference were evaluated using a questionnaire 24 hours after each visit

Secondary Outcome Measures

Name	Time	Method
1. The onset of sedation was measured as the minimum time interval required for child to become drowsy after administering the oral midazolam at each visit<br>2. The time that elapses between the child becoming drowsy (sedation score = 4) and when the patient become alert and awake (sedation score = 5 or 6) was measured as the working time at each visit