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Mogensen S, Treldal C, Kristensen CA, et al. Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study. Pain Rep. 2017;2(5):e619doi: 10.1097/PR9.0000000000000619.
Mogensen, S., Treldal, C., Kristensen, C. A., Bentzen, J., Lawson-Smith, L., Petersen, J., & Andersen, O. (2017). Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study. Pain reports, 2(5), e619. https://doi.org/10.1097/PR9.0000000000000619
Mogensen, Stine, et al. "Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study." Pain reports vol. 2,5 (2017): e619. doi: https://doi.org/10.1097/PR9.0000000000000619
Mogensen S, Treldal C, Kristensen CA, Bentzen J, Lawson-Smith L, Petersen J, Andersen O. Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study. Pain Rep. 2017 Aug 23;2(5):e619. doi: 10.1097/PR9.0000000000000619. eCollection 2017 Sep. PMID: 29392234; PMCID: PMC5777682.
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Pain Rep. 2017 Aug 23;2(5):e619. doi: 10.1097/PR9.0000000000000619. eCollection 2017 Sep.

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

Pain reports

Stine Mogensen, Charlotte Treldal, Claus A Kristensen, Jens Bentzen, Louise Lawson-Smith, Janne Petersen, Ove Andersen

Affiliations

  1. Clinical Research Centre, Copenhagen University Hospitals, Amager and Hvidovre, Denmark.
  2. Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  3. Department of Oncology, Copenhagen University Hospital, Herlev, Herlev, Denmark.
  4. Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark.

PMID: 29392234 PMCID: PMC5777682 DOI: 10.1097/PR9.0000000000000619

Abstract

INTRODUCTION: A nonblinded parallel-group randomized controlled study investigated the efficacy and tolerability of repeated administration of a bupivacaine lozenge (25 mg) as pain management for oral mucositis pain in head and neck cancer patients as add-on to standard systemic pain management.

OBJECTIVE: The primary end point was the difference between the intervention group (Lozenge group) and the Control group in daily mean pain scores in the oral cavity or pharynx (whichever was higher).

METHOD: Fifty patients from 2 hospitals in Denmark were randomized 1:1 to 7 days of treatment with bupivacaine lozenges (taken up to every 2 hours) plus standard pain treatment minus topical lidocaine (Lozenge group) or standard pain treatment including topical lidocaine (Control group). The efficacy analysis included 38 patients, as 12 patients were excluded because of changes in study design and missing data.

RESULTS: Mean pain in the oral cavity or pharynx (whichever was higher) was significantly lower 60 minutes after taking lozenges (35 mm [n = 22]) than for the Control group (51 mm [n = 16]) (difference between groups -16 mm, 95% confidence interval: -26 to -6,

CONCLUSION: These results show that the bupivacaine lozenge as an add-on to standard pain treatment had a clinically significant pain-relieving effect in patients with oral mucositis.

CLINICALTRIALSGOV: NCT02252926.

Keywords: Bupivacaine; Head and neck cancer; Local anesthetic; Lozenge; Oral mucositis; Pain management

Conflict of interest statement

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

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