Evidence map›Paper›PMID 27956393›Full record

Trial reportCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2017

Relative effectiveness of additive pain interventions during vaccination in infants.

Anna Taddio, Rebecca Pillai Riddell, Moshe Ipp, Steven Moss, Stephen Baker, Jonathan Tolkin, Dave Malini, Sharmeen Feerasta, Preeya Govan, Emma Fletcher and 4 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
8.5field-weighted citation impact, top 3% 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

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Non-pharmacological management of infant and young child procedural pain.The Cochrane database of systematic reviews · 2023
    Pooled it
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Efficacy of topical lidocaine-prilocaine (EMLAPaediatric & neonatal pain · 2022
    Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Improving the treatment of infant pain.Current opinion in supportive and palliative care · 2017
    Review
  17. Article
  18. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Anna TaddioLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont. anna.taddio@utoronto.ca.
Rebecca Pillai RiddellLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Moshe IppLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Steven MossLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Stephen BakerLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Jonathan TolkinLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Dave MaliniLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Sharmeen FeerastaLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Preeya GovanLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Emma FletcherLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Horace WongLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Caitlin McNairLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Priyanjali MithalLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
Derek StephensLeslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont.
3M (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVaccine injections can cause acute pain and distress in infants, which can contribute to dissatisfaction with the vaccination experience and vaccine hesitancy. We sought to compare the effectiveness of additive pain interventions administered consistently during vaccine injections in the first year of life.

methodsWe conducted a multicentre, longitudinal, double-blind, add-on, randomized controlled trial. Healthy infants were randomly assigned to 1 of 4 levels of pain management for all vaccine injections at 2, 4, 6 and 12 months: (i) placebo control; (ii) parent-directed video education about infant soothing; (iii) the video plus sucrose administered orally or (iv) the video plus sucrose plus liposomal lidocaine applied topically. All infants benefit from injection techniques that minimize pain. We used a double-dummy design; hence all parents watched a video (active psychological intervention or placebo) and all infants received oral solution (sucrose or placebo) and topical cream (lidocaine or placebo). We assessed infant distress during 3 phases - preinjection (baseline), vaccine injection (needle), and 1 minute postinjection (recovery) - using the Modified Behavioural Pain Scale (range 0-10). We compared scores between groups and across infant ages using a mixed-model repeated-measures analysis.

resultsA total of 352 infants participated in the study, from Jan. 17, 2012, to Feb. 2, 2016. Demographics did not differ among intervention groups (

interpretationOnly liposomal lidocaine provided consistent analgesia within an additive pain intervention regimen during vaccinations in infants.

Indexed as

Acute PainAdministration, CutaneousAnesthetics, LocalAudiovisual AidsDouble-Blind MethodFemaleHumansInfantInfant CareInjectionsLidocaineLiposomesLongitudinal StudiesMalePain ManagementPain MeasurementAnesthetics, LocalLidocaineLiposomesSucroseSweetening AgentsVaccines

Identifiers

PMID27956393
PMCPMC5305402
OpenAlexW2561345353

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.