Evidence map›Paper›PMID 30782698›Full record

ArticleBMJ open2019

External cold and vibration for pain management of children undergoing needle-related procedures in the emergency department: a randomised controlled non-inferiority trial protocol.

Ariane Ballard, Christelle Khadra, Samara Adler, Evelyne D Trottier, Benoit Bailey, Naveen Poonai, Jean Théroux, Sylvie Le May

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02616419 (External Cold and Vibration Stimulation), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT02616419 nacompletednot on this map

External Cold and Vibration Stimulation (Buzzy® Device) VS Topical Anesthetic Cream for Procedural Pain Management in Children Undergoing Needle-Related Procedures in the Emergency Department : A Randomized Controlled Non-Inferiority Trial

TypeinterventionalSponsorSt. Justine's HospitalRan2017 to 2018Enrolled354ConditionsChild, Pain Due to Certain Specified ProceduresArmsBuzzy® device, Maxilene® (Lidocaine liposomal 4%)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
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  4. Trial
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  6. Review
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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

8 authors.

Ariane BallardFaculty of Nursing, University of Montreal, Montreal, Quebec, Canada.
Christelle KhadraFaculty of Nursing, University of Montreal, Montreal, Quebec, Canada.
Samara AdlerFaculty of Medicine, University of Montreal, Montreal, Quebec, Canada.
Evelyne D TrottierDivision of Emergency Medicine, Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada.
Benoit BaileyDivision of Emergency Medicine, Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada.
Naveen PoonaiDepartment of Emergency Medicine, London Health Sciences Centre, London, Ontario, Canada.
Jean ThérouxSchool of Health Professions, Murdoch University, Murdoch, Western Australia, Australia.
Sylvie Le MayFaculty of Nursing, University of Montreal, Montreal, Quebec, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNeedle-related procedures are considered as the most important source of pain and distress in children in hospital settings. Considering the physiological and psychological consequences that could result from these procedures, management of pain and distress through pharmacological and non-pharmacological methods is essential. Therefore, it is important to have interventions that are rapid, easy-to-use and likely to be translated into clinical practice for routine use. The aim of this study will be to determine whether a device combining cold and vibration (Buzzy) is non-inferior to a topical anaesthetic (liposomal lidocaine 4% cream) for pain management of children undergoing needle-related procedures in the emergency department. METHODS AND ANALYSIS: This study will be a randomised controlled non-inferiority trial comparing the Buzzy device to liposomal lidocaine 4% cream for needle-related pain management. A total of 346 participants will be randomly assigned in a 1:1 ratio to one of the two study groups. The primary outcome will be the mean difference in pain intensity between groups during needle-related procedures. A non-inferiority margin of 0.70 on the Color Analogue Scale will be considered. A Non-inferiority margin of 0.70 on the Color Analogue Scale will be considered. The secondary outcomes will be the level of distress during the procedure, the success of the procedure at first attempt, the occurrence of adverse events, the satisfaction of both interventions and the memory of pain 24 hours after the procedure. The primary outcome will be assessed for non-inferiority and the secondary outcomes for superiority. ETHICS AND DISSEMINATION: This study protocol was reviewed and approved by the institutional review board of the study setting. Findings of this trial will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02616419.

Indexed as

Cold TemperatureAnesthetics, LocalCatheterization, PeripheralChildEmergency Service, HospitalEquivalence Trials as TopicHumansLidocaineNeedlesPain ManagementPhlebotomyVibrationAnesthetics, LocalLidocainebuzzychildrennon-pharmacological interventionpain managementtopical anesthetic

Identifiers

PMID30782698
PMCPMC6340451

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.