Open-label, Prospective Study to Assess the Safety, Tolerability, Analgesic Effect and Feasibility of Intranasal Sufentanil/Ketamine in Pediatric Patients With Moderate or Severe Pain, in an Acute Care Setting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 7
- 主要终点
- Sedation
研究概览
简要总结
The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric participant, age 1 year to 17 years
- •Attending an Emergency Department following an injury
- •Acute pain of moderate or severe intensity
- •Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)
排除标准
- •Participant showing abnormal nasal cavity/airway such as:
- •major septal deviation
- •evidence of previous nasal disease or surgery
- •current significant nasal congestion due to common cold
- •Has received treatment with sufentanil and/or ketamine during the last 72 hours
- •Known or suspected allergy to ketamine or sufentanil
- •Critical, life- or limb-threatening condition requiring immediate management
研究组 & 干预措施
CT001
干预措施: CT001 (Drug)
结局指标
主要结局
Sedation
时间窗: At baseline and 10, 15, 20, 30, 45 and 60 min after first IMP administration. If a second IMP dose was needed, sedation score was performed at the timepoints relative to first IMP administration.
Sedation was assessed by sedation score on the University of Michigan Sedation Scale (UMSS). Scores range from 0 to 4, where 0 = awake/alert, 1 = minimally sedated (tired/sleepy, appropriate response to verbal conversation and/or sound), 2 = moderately sedated (somnolent/sleeping, easily aroused with light tactile stimulation or simple verbal command), 3 = deeply sedated (deep sleep, arousable only with significant physical stimulation), and 4 = unarousable. Lower scores indicate less sedation; higher scores indicate deeper sedation.
Respiratory Depression
时间窗: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Respiratory depression assessed by respiratory rate.
Peripheral Oxygen Saturation
时间窗: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Peripheral oxygen saturation assessed by oxygen saturation rate (%)
Cardiovascular Stability
时间窗: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Cardiovascular stability assessed by pulse rate (bpm)
Number of Reported Adverse Events
时间窗: Through study completion; up to 7 days
Number of reported adverse events.
Number of Adverse Events (AEs) Reported Per Participant
时间窗: Through study completion; up to 7 days
Number of adverse events (AEs) reported per participant.
Local Nasal Irritation
时间窗: 30 and 60 min post IMP administration
The number of participants with nasal irritation was summarised using counts of participants for each timepoint (30 and 60 min post IMP administration) by type of nasal irritation.
Analgesic Effect
时间窗: At baseline and at 15 and 30 min post first IMP dose
Number and proportion of participants that respond to the treatment relative to baseline (i.e. reduction in pain score to 4 or below). Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-\<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-\<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).
次要结局
- Treatment Satisfaction(Prior to Emergency Department discharge (day of IMP administration))
- Feasibility (Acceptance of Nasal Administration)(Prior to Emergency Department discharge (day of IMP administration))
- Medication Errors(Assessed immediately post IMP administration)
- Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration.(30 min post (first) IMP administration)
- Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline(within 30 min post (first) IMP administration.)
- Change From Baseline in Pain Intensity(at 10, 15, 20, 30, 45 and 60 min post last dose of IMP administration.)
- Number of Children Receiving Additional Analgesics(During the 60 min period post last dose of IMP)