Opioids--Interventions for Pain Management

To evaluate the safety and efficacy of transdermal fentanyl for oral mucositis pain

Transdermal fentanyl was given at a rate of 25 mcg per hour to patients with pain scores greater than five during treatment and increased by 25 mcg per hour to maintain pain scores less than or equal to three on a numeric rating scale. Study assessments were done on days 1, 4, 7, and 10. Patients rated pain daily.

• N = 78
• MEDIAN AGE = 41 years (range = 31–52 years)
• MALES: 75.6%, FEMALES: 24.4%
• KEY DISEASE CHARACTERISTICS: All participants had nasopharyngeal cancer and were receiving daily radiation therapy of prescribed doses of 70 Gy to the planning target volume. Patients also were receiving chemotherapy of cisplatin with 5-FU or taxol and cisplatin.

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: China

PHASE OF CARE: Active antitumor treatment

Open-label, observational trial

• Pain numeric rating scale
• Score for pain, Physical activity levels, Additional pain medication, Additional physician/emergency room visits, Sleep, Mood, and Side effects (SPAASMS)

Mean pain scores declined from 7.41 before treatment to 5.54 (SD = 0.86, p < 0.001) on day 1 and 2.82 (SD = 0.68, p < 0.001) on day 10. Sleep quality was improved after treatment (p < 0.001). The most frequent side effect was nausea and vomiting. No patients discontinued treatment.

Transdermal fentanyl was quickly effective in reducing pain from oral mucositis in this patient population. Pain reduction was associated with improved sleep.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: The method of sleep quality measurement was not described. The final doses of fentanyl were not reported.

The findings of this study demonstrated that transdermal fentanyl was effective in reducing oral mucositis-related pain within one day, and pain scores continued to decline during combined radiation and chemotherapy. They also suggested that adequate pain control in this patient population improves sleep quality and other aspects of quality of life.

To evaluate the efficacy of ​hydromorphone-OROS (HM-OROS) in the treatment of sleep disturbances associated with cancer-related pain

Patients took an equianalgesic dose of HM-OROS for two weeks. The dose of HM-OROS was individualized and based on the total dose of previous opioids that were administered on the last day of the screening phase.

• N = 82  
• MEDIAN AGE = 56.1 years (SD = 11.2 years)
• MALES: 67.9 %, FEMALES: 32.1%
• KEY DISEASE CHARACTERISTICS: Patients with cancer; ≥ 20 years of age; cancer pain ≥ 4 on a numeric rating scale (NRS); sleep disturbance ≥ 4 NRS; using oral opioids for cancer-related pain management
• OTHER KEY SAMPLE CHARACTERISTICS: 81.1% stage IV cancer; colorectal 11%; lung 9.5%; pancreas 9%; stomach 8%; breast 7%; 75% prior chemotherapy, radiation, or surgery

• SITE: Multi-site
• SETTING TYPE: Outpatient facility at a university
• LOCATION: Korea

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care

Multicenter, prospective, open-label study with a pre- and post-test

• Sleep disturbance NRS
• Number of times awake after sleep onset
• Pain score
• Need for analgesia for pain prior to bedtime to facilitate sleep
• Korean Brief Pain Inventory (K-BPI)

• The NRS pain score was reduced from 5.3 to 4.1 (p < 0.01).
• The NRS sleep disturbance score was reduced from 5.9 to 4.1 (p < 0.01).
• 26.8% of participants reported a 50% improvement in sleep disturbance, 58.5% reported a 30% improvement in sleep disturbance, and 85% reported an improvement of 10%.
• The K-BPI showed that pain, mood, walking ability, normal work, and sleep improved. The mean sleep score changed from 5.9 to 4.2 (p < 0.01).

HM-OROS improved sleep disturbances in patients with moderate to severe cancer-related pain.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: There was a very high initial number of participants that was reduced by 82 (50%). The initial sample described included 190 participants.

HN-OROS may be an effective drug to treat cancer-related pain and improve sleep disturbance.