Title
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain
Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial
Phase
Phase 2Lead Sponsor
Korea Research FoundationStudy Type
InterventionalStatus
Completed Results PostedIntervention/Treatment
caffeine sodium chloride ...Study Participants
41Pain 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.
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.
Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.
Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
Intravenous injections of 100ml of normal saline over 1 hour
Inclusion Criteria: 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 Exclusion Criteria: 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)
| Event Type | Organ System | Event Term | Caffeine | Placebo |
|---|
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.
Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.
Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.
Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.
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.
