Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Adverse Drug Reaction
研究概览
简要总结
The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 3-17 years old
- •Condition (medical or trauma) requiring opioid pain management per standard of care
- •Need to establish an IV per standard of care
- •Treating physician agrees to manage the patient's pain with morphine following randomization.
排除标准
- •Trauma Team Activation
- •Known allergy to ketamine
- •Family member unable/unavailable to provide informed consent
- •When appropriate, patient unwilling to provide assent
- •High suspicion of injury related to child abuse
- •Patient and/or family member is non-English speaking
- •Patient is incarcerated
研究组 & 干预措施
Ketamine
Ketamine, single dose, 0.3 mg/kg, IV
干预措施: Ketamine (Drug)
Morphine
Morphine, single dose, 0.05 mg/kg, IV
干预措施: Morphine (Drug)
结局指标
主要结局
Adverse Drug Reaction
时间窗: 3 hours post study drug administration
Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.
Cumulative Narcotic Consumption
时间窗: 3 hours post study drug administration
All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.
次要结局
未报告次要终点