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Effectiveness of two sedative drugs on pediatric patients during dental treatment

Intranasal fentanyl combined with oral midazolam for pediatric dental sedation: a controlled randomized blinded cross-over clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13661311
Enrollment
32
Registered
2021-11-23
Start date
2019-09-26
Completion date
Unknown
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation of pediatric patients during dental treatment Oral Health

Interventions

Children between 3 and 6 years old referred to the pediatric dental clinics at Dental University Hospital, King Khaled Medical City, King Saud University for dental treatment under moderate sedation w

Sponsors

King Saud University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. The sedation scores were recorded using the Modified Observer’s Alertness/ Sedation Scale (MOAA/S) after sedation at each visit 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 3. Post-discharge adverse effects and parental satisfaction and preference were evaluated using a questionnaire 24 hours after each visit

Secondary

MeasureTime frame
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 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

Countries

Saudi Arabia

Contacts

Public ContactRoaa Alhaidari
437203478@student.ksu.edu.sa+966 551381409

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026