A novel lozenge containing bupivacaine as topical alleviation of oral mucositis pain in patients with head and neck cancer: a pilot study

Abstract

Introduction: Oral mucositis induces severe oral pain in head and neck cancer patients. There is at this point no effective pain treatment without considerable side effects.Objective: The aim of this pilot study was to investigate pain reduction in oral cavity and pharynx in patients with head and neck cancer (HNC) with oral mucositis, the location of anesthetic effect, and duration of pain relief, after a single-dose administration of a 25 mg bupivacaine lozenge.Methods: Ten patients with HNC suffering from oral mucositis pain were included. The patients assessed pain in the oral cavity and pharynx on a visual analogue scale (from 0 to 100 mm) at baseline and up to 3 hours after the lozenge was dissolved. Possible adverse events were registered.Results: The baseline pain was 51 mm (range: 30–73 mm) in the oral cavity and 58 mm (range: 35–70 mm) in the pharynx. When the lozenge was dissolved, both oral (−27 mm; range: −3 to −52 mm; P = 0.0003) and pharynx pain (−20 mm; range: −3 to −45 mm; P = 0.008) were significantly reduced. After 180 minutes, the mean reduction in pain was significant in the oral cavity (−18 mm; range: −8 to −30 mm; P < 0.0001) but not in the pharynx (−8 mm; range: +4 to −23 mm; P = 0.12). No adverse events were observed.Conclusion: The results indicate that the bupivacaine lozenge has a clinically significant and long-lasting pain-relieving effect on pain because of oral mucositis in patients with HNC.

Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study

“…Possible explanations for the lower than anticipated consumption include that the lozenges may have had a prolonged pain-relieving effect, as shown previously. 12 There is an immediate need for improved pain management in patients with head and neck cancer with oral mucositis.…”

“…The power calculation was based on pain scores (VAS) from 10 patients with head and neck cancer from a previous study 12 and was based on a paired t test. With a minimum clinically relevant difference in pain between the 2 groups of 15 mm, a mean baseline pain of 57 mm, an SD of 15 mm, 80% power, and a significance level of 0.05; it resulted in a sample size of 32 patients completing the study.…”

“… 10 , 11 Moreover, a pilot study in which a single dose of the lozenge was administered to patients with head and neck cancer showed a strong, long-lasting pain-relieving effect, with a mean duration of maximum pain relief in the oral cavity of 42 minutes and a significant pain relief even after 180 minutes. 12 Lidocaine viscous solution has been reported to have a duration of 15 to 20 minutes. 6 …”

Advances in the treatment and intervention modalities of radiation oral mucositis

“…Anaesthetics: Lidocaine mouthwash can relieve mild to moderate oral pain, but its duration of action is short, and its long-term use is associated with greater long-term side effects, making its clinical application more restrictive. Bupivacaine in tablet form can effectively relieve oral pain in patients undergoing radiotherapy for head and neck tumours without serious side effects [14].…”