Comparison of Intramuscular Ketamine and Intranasal Nalbuphine and Dexmedetomidine for Analgosedation in Children Undergoing Suture Removal After Surgery for Congenital Clefts of the Palate, Alveolar Ridge, and Lip
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to achieve adequate sedation (Modified Ramsay Sedation Score 2-3)
研究概览
简要总结
This prospective, randomized study is designed to compare the efficacy and safety of three sedative-analgesic agents-intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine-for procedural sedation in children undergoing suture removal following cleft palate, alveolar ridge, or lip surgery. The study will include 60 children aged 6 months to 3 years, randomly assigned to one of three intervention groups.
The primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs.
All study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.
详细描述
Title: Comparison of Intramuscular Ketamine and Intranasal Nalbuphine and Dexmedetomidine for Analgosedation in Children Undergoing Suture Removal After Surgery for Congenital Clefts of the Palate, Alveolar Ridge, and Lip
Introduction Orofacial clefts, including cleft lip with or without cleft palate and isolated cleft palate, are among the most common congenital craniofacial anomalies. Primary correction of a cleft lip may be performed between the 6th week and the 6th month of life, considering the child's growth, identification of associated anomalies, and avoidance of general anesthesia in the neonatal period. In cases of congenital cleft palate or alveolar ridge, correction is typically completed between 6 and 12 months of age.
Suture removal following these surgeries is a short procedure that requires optimal sedation and analgesia to enable efficient, rapid, and safe completion. The American College of Emergency Physicians (ACEP) defines procedural sedation as "a technique of administering sedatives or dissociative agents with or without analgesics to facilitate a procedure while maintaining cardiorespiratory function." The goal of sedation in pediatric patients is to avoid fear of medical professionals, injections, surgery, and the operating room environment. Effective sedation improves safety and comfort, reduces pain and anxiety, enhances the possibility of amnesia, and minimizes psychological trauma from separation from parents and exposure to an unfamiliar environment.
Ketamine is a dissociative anesthetic and analgesic, an NMDA receptor antagonist synthesized in 1962. It is favored for its analgesic and amnestic effects, preservation of airway reflexes, and various routes of administration (IV, IM, oral, rectal, nasal, epidural, intrathecal). However, ketamine may cause unpleasant hallucinations and hypersalivation. It is relatively contraindicated in patients with hypertension, increased intracranial pressure, respiratory infections, or underlying neuropsychiatric disorders.
Dexmedetomidine, approved by the FDA in 1999, is a selective α2-adrenoceptor agonist with strong sedative, analgesic, and anxiolytic properties, commonly used in pediatric intensive care units and diagnostic/therapeutic procedures. It may cause hypotension and bradycardia. Literature describes its pediatric use in intraoperative sedation, delirium management, postoperative analgesia, and shivering prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. No participants, investigators, or outcome assessors are blinded to the treatment allocation.
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months to 3 years
- •Scheduled for suture removal after surgery for congenital cleft of the palate, alveolar ridge, or lip
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Written informed consent obtained from parents or legal guardians
- •Slovene-speaking family to ensure understanding and compliance
- •No contraindications to the use of study medications
排除标准
- •Known allergy or hypersensitivity to ketamine, nalbuphine, or dexmedetomidine
- •ASA physical status greater than II
- •Significant neurological, psychiatric, or respiratory disorder
- •Active or recent upper respiratory tract infection
- •Refusal of parental or guardian consent
- •Developmental disorder affecting communication or cooperation
研究组 & 干预措施
Intramuscular Ketamine
Participants assigned to this arm will receive intramuscular ketamine at a dose of 4 mg/kg body weight for analgosedation during suture removal after surgery for congenital clefts. In addition, glycopyrrolate 4 mcg/kg will be administered intramuscularly to reduce salivation. This arm represents the control group, following the established clinical protocol.
干预措施: ketamine (Drug)
Intranasal Nalbuphine
Participants assigned to this arm will receive intranasal nalbuphine at a dose of 0.5 mg/kg body weight, administered using a mucosal atomizer device (MAD), for analgosedation during suture removal after cleft surgery. This intervention will be evaluated for its effectiveness, ease of administration, and safety compared with intramuscular ketamine.
干预措施: Nalbuphine (Drug)
Intranasal Dexmedetomidine
Participants assigned to this arm will receive intranasal dexmedetomidine at a dose of 3 mcg/kg body weight, administered using a mucosal atomizer device (MAD), for analgosedation during suture removal after cleft surgery. The intervention will be evaluated for sedation depth, response to separation from parents, and overall procedural ease compared with other sedative agents.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Time to achieve adequate sedation (Modified Ramsay Sedation Score 2-3)
时间窗: Perioperatively, from drug administration until Modified Ramsay score 2-3 is achieved (typically within 5-20 minutes)
Time in minutes from administration of the study drug until the child reaches adequate sedation, defined as a Ramsay Sedation Score of 2-3. Sedation is assessed every 5 minutes by a trained clinician. Unit of Measure: Minutes
Sedation depth before procedure (Modified Ramsay Sedation Scale)
时间窗: Periprocedural (every 5 minutes for up to 20 minutes after study drug administration, until procedure begins)
Sedation depth is measured using the Modified Ramsay Sedation Scale (1 = anxious/agitated, 6 = no response; 2-3 = adequate sedation). A trained clinician assesses sedation every 5 minutes after administration of the study drug, until the start of the suture removal procedure.
Surgeon-rated ease of surgical procedure
时间窗: Within 5 minutes after completion of suture removal
Ease of suture removal as rated by the operating surgeon using a 5-point Likert scale (1 = very difficult, 5 = very easy). Unit of measure: Units on a scale
Time to discharge from recovery room
时间窗: Perioperative (every 5 minutes post-procedure until Modified Aldrete Score ≥9 is achieved or until discharge from the recovery area, up to 90 minutes)
Time in minutes from the end of the surgical procedure until the child reaches a Modified Aldrete Score of ≥9, indicating readiness for discharge from the recovery area to the hospital ward. The Aldrete score is assessed every 5 minutes by recovery room nursing staff. Unit of Measure: Minutes
Discharge readiness (Modified Aldrete Score)
时间窗: Postprocedural (every 5 minutes in recovery room until Modified Aldrete Score ≥9 is reached, up to 90 minutes post-procedure)
Discharge readiness assessed using the Modified Aldrete Score (range: 0-10; score ≥9 indicates clinical criteria for transfer to ward). Unit of Measure: Units on a scale
次要结局
- Baseline child behavior (Ohio Behavioral Rating Scale)(Baseline (within 5 minutes prior to study drug administration during the procedure))
- Child's response to drug administration(Periprocedural (immediately during study drug administration))
- Child's behavior during separation from parent(Periprocedural (immediately at the time of parent-child separation))
- Use of rescue Sevoflurane due to inadequate sedation(Intraoperatively, during the suture removal procedure)
- Sedation level measured by Modified Ramsay Sedation Scale during procedure(From drug administration until end of suture removal procedure (expected duration up to 30 minutes))
- Parental satisfaction with sedation(Collected immediately after completion of procedure.)