Comparison of Sub-dissociative Intranasal Ketamine Plus Standard Pain Therapy Versus Standard Pain Therapy in the Treatment of Pediatric Sickle Cell Disease Vasoocclusive Crises in Resource-limited Settings: a Multi-centered, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change from Baseline (time zero) in FPS-R scores between treatment groups
研究概览
简要总结
The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises in resource-limited settings.
详细描述
This is a randomized, placebo-controlled, drug trial using sub-dissociative intranasal ketamine as an adjunct to standard pharmacotherapy for the management of pediatric sickle cell disease vasoocclusive pain crises in resource-poor settings. Pediatric patients will be enrolled at a teaching and referral hospital in West Africa. Patients will be randomly assigned to the treatment arm - standard therapy plus sub-dissociative intranasal ketamine (1 mg/kg) given at time zero) or the control arm - standard therapy plus intranasal normal saline (volume-matched to treatment arm), and patients will evaluated at standard intervals to assess for pain scores and vital signs (0 minutes, 30 minutes, 60 minutes, and 120 minutes). Pain will be assessed using the Faces Pain Scale - Revised (FPS-R). Patients will also be observed for any potential side effects or adverse events. All patients will be contacted 2-3 weeks post intranasal medication administration for over-the-phone follow-up using a portion of the PedsQL-SCD questionnaire, to assess for basic quality of life related to pain management and treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sickle cell disease (SCD)
- •Vasoocclusive pain crisis
- •Requiring analgesia
排除标准
- •Anatomic variations of nose precluding intranasal medication administration
- •Ketamine allergy
- •Non-verbal
- •Other acute SCD complications:
- •Acute chest syndrome
- •Splenic sequestration
- •Pulmonary embolism
- •Acute osteomyelitis
研究组 & 干预措施
Intranasal Ketamine
Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
干预措施: Ketamine (Drug)
Intranasal Ketamine
Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
干预措施: Standard Pain Therapy (Other)
Intranasal Ketamine
Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
干预措施: Pediatric Quality of Life - Sickle Cell Disease Module (Other)
Intranasal Ketamine
Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
干预措施: Faces Pain Scale - Revised (Other)
Normal Saline
Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
干预措施: Normal Saline (Drug)
Normal Saline
Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
干预措施: Standard Pain Therapy (Other)
Normal Saline
Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
干预措施: Pediatric Quality of Life - Sickle Cell Disease Module (Other)
Normal Saline
Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
干预措施: Faces Pain Scale - Revised (Other)
结局指标
主要结局
Change from Baseline (time zero) in FPS-R scores between treatment groups
时间窗: Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes
Measure of differences of change of FPS-R scores from baseline to 30 minutes, 60 minutes, and 120 minutes compared between treatment arms
次要结局
- Hospital length of stay(through study completion, an average of 3 days)
- Analgesia use - paracetamol(Time of initial intranasal drug administration to 2 hours post intranasal drug administration)
- Analgesia use - opioids(Time of initial intranasal drug administration to 2 hours post intranasal drug administration)
- Quality of life assessment (PedsQL-SCD Module scores)(Time of first intranasal administration to 3 weeks post intranasal intervention.)
- Analgesia use - ibuprofen(Time of initial intranasal drug administration to 2 hours post intranasal drug administration)