Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
研究概览
简要总结
Neuraxial narcotics are commonly used in obstetric patients for cesarean delivery to help with pain control over the first 24 hours after the surgery. The aim is to evaluate effectiveness of promethazine (IMP) treatment of intrathecal morphine induced pruritus (ITIMIP). A treatment for ITMIP, other than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.
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)
盲法说明
Stratified randomization design
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
- •Willing to consent to study.
排除标准
- •Male patients
- •Incarceration
- •Inability to communicate with the investigators
- •Allergies to any medications used in the study
- •Possessing any contraindication to spinal anesthesia (lack of consent, elevated intracranial pressure, preexisting neurological disease, thrombocytopenia/coagulopathy, hypovolemia, infection at the site of the procedure)
- •Patients with an already prolonged QTc (>500 ms)
- •Any reason an investigator believes study participation would not be in the best interest of the potential subject.
研究组 & 干预措施
Promethazine
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
干预措施: Promethazine (Drug)
Placebo
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride
干预措施: Placebo (Drug)
结局指标
主要结局
Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
时间窗: Within first 24 hours after cesarean section
Pruritus (itching) will be quantified by the ItchyQuant Scale. The ItchyQuant scale is a 0 -10 scale with 0 denoting no itch and 10, the worst itch possible. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their itching. In the results here we reported any itching (a score greater than zero on the ItchyQuant scale) at 24 hours after surgery in each group.
次要结局
- Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?(Within first 24 hours post cesarean section)
- Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?(Within first 24 hours post cesarean section)