Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain
- Registration Number
- NCT00879775
- Lead Sponsor
- Korea Research Foundation
- Brief Summary
Pain is a most common symptom and it has a high impact on quality of life in cancer patients. Many cancer patients have received opioid therapy, but also many of them have suffered from side effects of opioids. Drowsiness and confusion are common side effects of opioids. Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the investigators aimed to prove the efficacy of intravenous caffeine administration as an adjuvant analgesics to opioids. At the same time, the investigators tried to find that the side effects of opioids could be ameliorated by caffeine.
- Detailed Description
Previous studies on cancer pain lacked assessment of quality of life. And most of previous studies on cancer pain did not give attention to symptoms accompanied with pain. We include such variables as outcome measures, and aimed to evaluate the efficacy and the safety of intravenous caffeine in advanced cancer inpatients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Advanced (Stage IV) cancer inpatients
- Adults aged over 18 years
- Patients who have received opioid therapy and whose pain scales are under 6 (by numeric rating scale)
- Patients who do not take caffeine beverage 48 hours before study period
- Volunteers who provided written informed consent
- Sensitivity (palpitation,headache,irritability,insomnia) to caffeine
- Uncontrolled hypertension and/or heart disease
- Liver failure (alanine aminotransferase >= 100 IU/L)
- Kidney failure (serum creatinine >= 2.0 mg/dL)
- Patients taken theophylline
- Gastroesophageal reflux disease
- Chronic glaucoma
- Cognitive impairment
- Progressive pain over 7 (by numeric rating scale)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Normal saline Intravenous injections of 100ml of normal saline over 1 hour Caffeine Caffeine Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
- Primary Outcome Measures
Name Time Method Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids two days Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; higher scores represent higher levels of pain, and possible side effects (drowsiness, confusion, nausea) of opioids.
Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids two days Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.
- Secondary Outcome Measures
Name Time Method Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10 two days Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.
Health-related Quality of Life two days Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.
Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) two days Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of impact of symptom burden to daily life.
Trial Locations
- Locations (2)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of