Evidence map›Paper›PMID 28190158›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2017

Treatment of severe mucositis pain with oral ketamine mouthwash.

Alexandra Shillingburg, Abraham S Kanate, Mehdi Hamadani, Sijin Wen, Michael Craig, Aaron Cumpston

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01566448 (Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01566448 phase2completednot on this map

Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

TypeinterventionalSponsorAaron Cumpston, PharmD, BCOPRan2012 to 2015Enrolled30ConditionsMucositisArmsKetamine
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Young head and neck cancer patients are at increased risk of developing oral mucositis and trismus.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Alexandra ShillingburgDepartment of Pharmacy, West Virginia University Medicine, P.O. Box 8045, Medical Center Drive, Morgantown, WV, 26506, USA. shillingburga@wvumedicine.org.ORCID 0000-0001-6128-3225
Abraham S KanateOsborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA.
Mehdi HamadaniDivision of Hematology/Oncology, Medical College of Wisconsin, Milwaukee, WI, USA.
Sijin WenDepartment of Biostatistics, West Virginia University Cancer Institute, Morgantown, WV, USA.
Michael CraigOsborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA.
Aaron CumpstonDepartment of Pharmacy, West Virginia University Medicine, P.O. Box 8045, Medical Center Drive, Morgantown, WV, 26506, USA.

Funding

West Virginia IDEA-CTRU54GM104942 · NIGMS · WEST VIRGINIA UNIVERSITY · PI Sally Lynn Hodder · 2012 to 2026
$81.0M
NIGMS NIH HHS U54 GM104942
6 · The paper itself

Abstract

purposeMucositis is a significant complication of intensive chemotherapy or hematopoietic cell transplantation (HCT), with few treatment options. Ketamine mouthwashes have been used for pain relief, but supporting evidence is limited. The primary objective of this study was to assess the reduction in pain intensity of stomatodynia and odynophagia compared to baseline assessment.

methodsThis open-label, prospective, phase II interventional study (NCT01566448) was conducted from February 2012 through July 2015. Patients with grade 3 or 4 oral mucositis according to the World Health Organization (WHO) scale as a result of chemotherapy were treated with ketamine mouthwash 20 mg/5 mL four times daily and every 4 h as needed.

resultsThirty patients were enrolled and a total of 136 assessments were conducted. A statistically significant reduction in pain scores of 2 and 3 points was achieved after 1 h and 3 days, respectively (p < 0.0001, p = 0.0003). Pain scores were significantly improved while swallowing, reduced 1 and 4 points at 1-h and 3-day assessment, respectively (p = 0.0006, p = 0.0001). No patients developed adverse effects related to ketamine administration.

conclusionKetamine mouthwashes resulted in clinically meaningful and statistically significant reduction in pain scores, have an acceptable safety profile, and can be a useful adjunctive treatment in the multi-modal management of severe mucositis.

Indexed as

AdultAgedFemaleHematopoietic Stem Cell TransplantationHumansKetamineMaleMiddle AgedMouthwashesMucositisPainProspective StudiesStomatitisYoung AdultKetamineMouthwashesKetamineMouthwashMucositisOralPainTransplant

Identifiers

PMID28190158
PMCPMC5500907

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.