Phase 2
Completed N=41
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain
Source: ClinicalTrials.gov NCT00879775 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids — 2.22; 3.10; 2.83; 3.05 scores
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids |
2.22; 3.10; 2.83; 3.05; 1.89; 2.20 | — |
| PRIMARY Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids |
3.53; 3.80 | — |
| SECONDARY Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10 |
3.61; 3.55 | — |
| SECONDARY Health-related Quality of Life |
4.83; 4.45 | — |
| SECONDARY Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) |
5.17; 5.95; 5.61; 5.60; 5.56; 6.75 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00879775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.