Comparative evaluation of Sedation Protocols for procedural sedation in Paediatric Dentistry: Dexmedetomidine(intranasal) plus Nitrous Oxide, Midazolam(intranasal) plus Nitrous Oxide and Nitrous Oxide Monotherapy for Uncooperative Patients- a crossover academic trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate sedation effectiveness using standard behavioral scales including Wood Mask Acceptance Scale, Frankl Behaviour Rating Scale, Houpt Behaviour Scale and AAPD Sedation Effectiveness Rank.
研究概览
简要总结
This is a prospective, randomized, crossover clinical trial conducted in a pediatric dental setting. The study aims to compare the effectiveness of three conscious sedation protocols in managing uncooperative pediatric dental patients: 1) intranasal dexmedetomidine with nitrous oxide, 2) intranasal midazolam with nitrous oxide, and 3) nitrous oxide monotherapy. Children aged 3 to 12 years, classified as negative or definitely negative according to the Frankl Behaviour Rating Scale, will be included. Each participant will receive all three interventions across separate visits in randomized order. Behavioural outcomes will be measured using Wood’s Mask Acceptance Scale, Frankl Scale, Houpt Behaviour Rating, and AAPD sedation effectiveness rank. Physiological parameters and adverse events will be monitored. The study will help identify the most effective and child-friendly sedation protocol for use in pediatric dental procedures. A total of 30 participants will be enrolled at a single centre in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Behavioural category: Frankl Behaviour Rating Scale negative and definitely negative.
- •2.Patient’s whose approval has been granted by anaesthesiologist for the proposed procedure.
- •Patient classified as American Society of Anaesthesiologist (ASA) physical status classification I and II.
- •Patients requiring a minimum of three dental procedures including deep restorations, pulpectomy, pulpotomy or extractions during the study period.
排除标准
- •Patients with conditions that may cause severe airway obstruction (e.g., adenoid hyperplasia, nasal septum issues, enlarged turbinates, nasal polyps) , with upper or lower respiratory tract infections, mouth breather or with chronic pulmonary disease.
- •Patient with history of middle ear surgery, otitis media or infections.10 Individuals exhibiting severe cognitive deficits.
- •Patients who have recently used medications such as bleomycin sulfate 10,erythromycin or anticonvulsants that may impact the pharmacokinetics of the drugs to be used.
- •Patient with any autoimmune disease or immunosuppressive therapy.10
- •Patient with methionine synthase deficiency, methylene tetrahydrofolate reductase deficiency or vitamin B12 deficiency10 .
- •Surgery which involves anterior surface of maxilla ( e.g.: extraction of an impacted tooth,
- •removal of odontomes and cysts ) Any prior diagnosis of systemic diseases that may affect sedation.
结局指标
主要结局
To evaluate sedation effectiveness using standard behavioral scales including Wood Mask Acceptance Scale, Frankl Behaviour Rating Scale, Houpt Behaviour Scale and AAPD Sedation Effectiveness Rank.
时间窗: Pre-sedation, during sedation, and immediate post-sedation
次要结局
- To assess physiological parameters (heart rate, blood pressure, oxygen saturation) and incidence of adverse effects (sneezing, vomiting, respiratory distress, etc.) across all three sedation protocol(Baseline (pre-sedation))
研究者
Aswathi Venugopal
AIIMS MANGALAGIRI