Morphine Mouthwash Versus Ketamine Mouthwash For Acute Pain In Patients Of Hematolymphoid Cancers With Chemotherapy Induced Oral Mucositis - A Randomised Controlled Study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Mean difference in the pain scores between the two arms as reported on the Numerical rating scale(NRS).
研究概览
简要总结
Patients of hematolymphoid cancers who receive intense chemotherapy develop a dreaded and painful condition called oral mucositis which potentiates the need for TPN, opioid analgesics and can also lead to interruption in the treatment and affects the overall quality of life.
We hypothesize that Ketamine mouthwash is more beneficial than the morphine mouthwash for treating acute severe pain of chemotherapy induced oral mucositis.
The aim of this study is to find out the effectiveness of Ketamine mouthwash versus morphine mouthwash in treating the moderate to severe oral mucositis pain due to chemotherapy.
The recruited patients will be randomised to either of the groups using computer generated sequence and will be treated using basic oral care guidelines along with morphine mouthwash in one group and ketamine mouthwash in another group.
The pain scores will be recorded at base line and will be recorded daily for 3 days and the scores at day 3 will be compared to baseline pain scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •18 years of age or older Received at least one dose of chemotherapy Having oral mucositis pain score on NRS more than or equal to 6 Able to do mouthwash without swallowing Able to sign the informed consent.
排除标准
- •Any documented previous hypersensitivity to ketamine Local oral infection Received prior ketamine or morphine doses by any route within 48 h of study initiation.
- •Pregnant or breastfeeding.
- •Patients with hypertension, history of epilepsy and any cardiac conditions.
- •History of any psychiatric disorder that is at the risk of exacerbation.
结局指标
主要结局
Mean difference in the pain scores between the two arms as reported on the Numerical rating scale(NRS).
时间窗: At Day 3.
次要结局
- Mean difference in the pain scores between the two arms at 30 mins and 1 hour as reported on the NRS.(At 30 minutes and 1 hour)
- To assess for the change in the grade of the oral mucositis as assessed by the WHO or CTCAE scale.(Day 3)
- To check the lowest pain score achieved during the course of 3 days using the numerical rating scale.(Day 3)
- Numbers and types of adverse effects occurred during the study as reported by the patient using NOSE and also the patient reported adverse effects for ketamine.(Day 3)
- Time to requirement of first systemic opioid analgesic in hours.(Day 3)
- Requirement of opioid analgesics expressed as oral morphine equivalents.(Day 3)
研究者
Dr. Jayita Deodhar
Tata Memorial Hospital