Evidence map›Paper›PMID 30349694›Full record

ArticleBritish journal of pain2018

Onset of analgesia by a topically administered flurbiprofen lozenge: a randomised controlled trial using the double stopwatch method.

Bernard Schachtel, Sue Aspley, Adrian Shephard, Emily Schachtel, Mary Beth Lorton, Tim Shea

Abstract read
In one paragraph

Article in British journal of pain, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
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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 at 3 institutions in 2 countries.

Bernard SchachtelSchachtel Research Company, Inc., Jupiter, FL, USA.
Sue AspleyReckitt Benckiser Healthcare Ltd, Slough, UK.
Adrian ShephardReckitt Benckiser Healthcare Ltd, Slough, UK.
Emily SchachtelSchachtel Research Company, Inc., Jupiter, FL, USA.
Mary Beth LortonSchachtel Research Company, Inc., Jupiter, FL, USA.
Tim SheaReckitt Benckiser, Parsippany, NJ, USA.
Bechtel (United States) · USReckitt Benckiser (United Kingdom) · GBReckitt Benckiser (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe double stopwatch (DSW) method for determining the onset of analgesic activity has been implemented extensively by investigators studying orally administered drugs.

objectiveThe aim of this randomised, placebo-controlled trial was to use the DSW method to determine the time to onset of analgesia of a single dose of a topically administered non-steroidal anti-inflammatory drug, flurbiprofen 8.75 mg lozenge.

methodsAdults with acute sore throat (n = 122) were examined to confirm the presence of tonsillopharyngitis (Tonsillo-Pharyngitis Assessment) and sore throat pain of at least moderate intensity (≥6 on a 0-10 Sore Throat Scale). Lozenges containing flurbiprofen 8.75 mg or inert ingredients (identically flavoured) were administered under double-blind conditions in the clinic while patients assessed pain and pain relief over 3 hours. Onset of analgesia was determined using the DSW method and reported as the Kaplan-Meier median time to meaningful relief. The median time to first perceived relief was also documented.

resultsAbout 78% of flurbiprofen-treated patients reported meaningful pain relief compared with 48% of placebo-treated patients (p < 0.01); median time to meaningful relief for flurbiprofen-treated patients was 43 minutes (placebo-treated patients were right-censored due to non-responsivity; p = 0.01). Median time to first perceived pain relief was 11 minutes for flurbiprofen-treated patients and 19 minutes for placebo-treated patients (p = 0.03). Flurbiprofen lozenge was well tolerated, with no serious adverse events occurring and no patient discontinuing due to an adverse event.

conclusionThese results indicate that the DSW method can be successfully applied to the evaluation of the onset of action of a locally administered analgesic in patients with acute sore throat, demonstrating that the onset of action (time to meaningful pain relief) of flurbiprofen lozenge was <45 minutes.

Indexed as

Double stopwatch methodflurbiprofenonset of actionpharyngitissore throattopical analgesia

Identifiers

PMID30349694
PMCPMC6194974
OpenAlexW2786908207

What OpenQuestion holds

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Registered trials

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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.