Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caffeine | Drug | — | UNRESOLVED |
| Normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Caffeine
- description
- Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
- interventionNames
- Drug: Caffeine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Intravenous injections of 100ml of normal saline over 1 hour
- interventionNames
- Drug: Normal saline
Primary outcomes (2)
- measure
- Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
- timeFrame
- two days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (3)
- BACKGROUNDMercadante S, Serretta R, Casuccio A. Effects of caffeine as an adjuvant to morphine in advanced cancer patients. A randomized, double-blind, placebo-controlled, crossover study. J Pain Symptom Manage. 2001 May;21(5):369-72. doi: 10.1016/s0885-3924(01)00249-4. PMID 11369156
- BACKGROUNDManfredi PL, Gonzales GR. Symptomatic uses of caffeine in patients with cancer. J Palliat Care. 2003 Spring;19(1):63-5. No abstract available. PMID 12710118
- BACKGROUNDBruera E, Watanabe S. Psychostimulants as adjuvant analgesics. J Pain Symptom Manage. 1994 Aug;9(6):412-5. doi: 10.1016/0885-3924(94)90179-1. PMID 7963794