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Cochrane Database of Systematic Reviews

Fentanilo intranasal para el tratamiento del dolor agudo en niños

Información

DOI:
https://doi.org/10.1002/14651858.CD009942.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 10 octubre 2014see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Anestesia

Copyright:
  1. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Adrian Murphy

    Correspondencia a: Paediatric Emergency Research Unit (PERU), Department of Emergency Medicine, National Children's Research Centre, Our Lady's Children's Hospital Crumlin; University College Dublin, Dublin, Ireland

    [email protected]

  • Ronan O'Sullivan

    National Children's Research Centre, Our Lady's Children's Hospital Crumlin, Dublin, Ireland

    Cork University Hospital, Cork, Ireland

  • Abel Wakai

    Emergency Care Research Unit (ECRU), Division of Population Health Sciences (PHS), Royal College of Surgeons in Ireland, Dublin 2, Ireland

  • Timothy S Grant

    Biostatistics and Programming, ICON Clinical Research, Dublin, Ireland

  • Michael J Barrett

    Paediatric Emergency Research Unit (PERU), Department of Emergency Medicine, National Children's Research Centre, Our Lady's Children's Hospital Crumlin; University College Dublin, Dublin, Ireland

  • John Cronin

    Paediatric Emergency Research Unit (PERU), Department of Emergency Medicine, National Children's Research Centre, Our Lady's Children's Hospital Crumlin; University College Dublin, Dublin, Ireland

  • Siobhan C McCoy

    Department of Emergency Medicine, Cork University Hospital, Cork, Ireland

  • Jeffrey Hom

    Departments of Pediatrics (Emergency) and Emergency Medicine, Stony Brook University School of Medicine, Stony Brook, USA

  • Nandini Kandamany

    Department of Emergency Medicine, Our Lady's Children's Hospital, Dublin, Ireland

Contributions of authors

Conceiving of the review: Ronan O'Sullivan (ROS)

Co‐ordinating the review: Adrian Murphy (AM)

Undertaking manual searches: AM

Screening search results: AM

Organizing retrieval of papers: Siobhan McCoy (SMC)

Screening retrieved papers against inclusion criteria: John Cronin (JC) and Michael J Barrett (MB)

Appraising quality of papers: JC and MB

Abstracting data from papers: Jeffrey Hom (JH) and SMC

Writing to authors of papers for additional information: AM

Providing additional data about papers: AM

Obtaining and screening data on unpublished studies: AM

Managing data for the review: AM

Entering data into Review Manager (RevMan 5.2): JC and Nandini Kandamany (NK)

Analysing RevMan statistical data: Timothy Grant (TG)

Performing other statistical analysis not using RevMan: TG

Interpreting data: ROS and Abel Wakai (AW)

Making statistical inferences: TG

Writing the review: AM

Securing funding for the review: ROS

Performing previous work that served as the foundation of the present study: AM

Serving as guarantor for the review (one review author): ROS

Taking responsibility for reading and checking the review before submission: ROS and AM

Sources of support

Internal sources

  • National Children's Research Centre, Ireland.

External sources

  • No sources of support supplied

Declarations of interest

Adrian Murphy: none known.

Ronan O'Sullivan: none known.

Abel Wakai: none known.

Timothy Grant: I began working at ICON Clinical Research on December 1, 2012. None of my work at ICON involves related areas, and all work is performed independently of the work I had previously completed in preparation of this review. My current work involves primarily oncology and vaccines, and no activities focus on anaesthesia or pain management. Neither I, Tim Grant, nor my employer, ICON Clinical Research, is in a position to benefit financially from this review; I have no conflicts of interest. This work was performed independently of my employment, and this work is related in no way to my employer.

Michael J Barrett: none known.

John Cronin: none known.

Siobhan C McCoy: none known.

Jeffrey Hom: none known.

Nandini Kandamany: none known.

Acknowledgements

We would like to thank Andy Smith (content editor), Cathal Walsh (statistical editor) and David Herd and Meredith Borland (peer reviewers) for help and editorial advice provided during preparation of the protocol for the systematic review and the full systematic review.

Version history

Published

Title

Stage

Authors

Version

2014 Oct 10

Intranasal fentanyl for the management of acute pain in children

Review

Adrian Murphy, Ronan O'Sullivan, Abel Wakai, Timothy S Grant, Michael J Barrett, John Cronin, Siobhan C McCoy, Jeffrey Hom, Nandini Kandamany

https://doi.org/10.1002/14651858.CD009942.pub2

2012 Jul 11

Intranasal fentanyl for the management of acute pain in children

Protocol

Adrian Murphy, Ronan O'Sullivan, Abel Wakai, Timothy Grant, Michael J Barrett, John Cronin, Siobhan C McCoy, Jeffrey Hom

https://doi.org/10.1002/14651858.CD009942

Differences between protocol and review

We made the following changes to the published protocol (Murphy 2012).

  1. Byline: Nandini Kandamany joined the review team.

  2. Searching other resources: We did not contact pharmaceutical companies.

  3. In the published protocol for this review, we intended to document the following in the 'Summary of findings' (SoF) table.

    1. Pain score reduction (using age‐appropriate validated pain scales) following administration of INF at multiple time points.

    2. Occurrence of adverse events post INF administration.

    3. Acceptability of INF administration among participants.

    4. Use of 'rescue analgesia' post INF administration.

    5. Participant and parental satisfaction as defined by study authors.

    6. Cost as defined by study authors.

    7. Mortality

However, the included studies did not document participant/parental satisfaction nor cost; therefore these were not included in the SOF table.

Notes

Feedback incorporated August 2015 (see Feedback)

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Child; Humans;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Intranasal fentanyl compared with intravenous morphine for the management of acute moderate to severe pain in children

Patient or population: children (aged < 18 years) with acute severe pain

Settings: emergency department

Intervention: intranasal fentanyl

Comparison: intravenous morphine

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Intravenous morphine

Intranasal fentanyl

Pain reduction (mean VAS)

Pain assessed before analgesia (0 min) and at 5, 10, 20 and 30 min after analgesia

0 min = 67

5 min = 42

10 min = 41

20 min = 35

30 min = 33

0 min = 68

5 min = 55

10 min = 46

20 min = 37

30 min = 37

67 participants

(1 study)

⊕⊕⊕⊕
high

Given no statistically significant difference between treatment arms, VAS scores were combined to form an overall VAS score for each time point. Combined VAS scores produced statistically significant reductions in pain at 5, 10 and 20 min after analgesia

Respiratory depression

No cases were reported in this study

No cases were reported in this study

67 participants

(1 study)

⊕⊕⊕
moderate

Dosage regimen for this study was calculated for 3 weight intervals. Inclusion of 21 children outside the weight intervals (1 less than 20 kg and 20 greater than
50 kg) may have resulted in most of these children receiving smaller per‐kilogram doses of IV morphine and INF, thereby reducing the potential occurrence of adverse events listed

Hypotension

No cases were reported in this study

No cases were reported in this study

67 participants

(1 study)

⊕⊕⊕
moderate

Dosage regimen for this study was calculated for 3 weight intervals. Inclusion of 21 children outside the weight intervals (1 less than 20 kg and 20 greater than
50 kg) may have resulted in most of these children receiving smaller per‐kilogram doses of IV morphine and INF, thereby reducing the potential occurrence of adverse events listed

Decreased level of consciousness

No cases were reported in this study

No cases were reported in this study

67 participants

(1 study)

⊕⊕⊕
moderate

Dosage regimen for this study was calculated for 3 weight intervals. Inclusion of 21 children outside the weight intervals (1 less than 20 kg and 20 greater than
50 kg) may have resulted in most of these children receiving smaller per‐kilogram doses of IV morphine and INF, thereby reducing the potential occurrence of adverse events listed

Intolerance to analgesia

1 participant complained of a momentary flush at the IV site following administration of morphine

4 participants; 3 participants reported a "bad taste" following INF administration, 1 participant vomited 20 min following INF administration

67 participants

(1 study)

⊕⊕⊕⊕
high

Use of ED "rescue" analgesia

1 participant required 5 additional doses of IV morphine (protocol violation)

1 participant required 6 additional doses of INF (protocol violation)

67 participants

(1 study)

⊕⊕⊕
moderate

Protocol violation in control and intervention arms of this trial. As per protocol, participants should receive only 4 additional doses of either agent

*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

ED: Emergency department.

IV: Intravenous.

INF: Intranasal fentanyl.

VAS: Visual analogue scale.
Figuras y tablas -
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Table 1. Intranasal fentanyl (INF) versus intravenous morphine (IVM)

0 min

5 min

10 min

20 min

30 min

Intravenous morphine (mm)

67

42

41

35

33

Intranasal fentanyl (mm)

68

55

46

37

37

Difference (mm) (95% CI)

‐1 (‐12 to 9)

‐13 (‐23 to ‐3)

‐5 (‐16 to 7)

‐2 (‐13 to 10)

‐4 (‐16 to 8)

Borland 2007: Mean visual analogue score (mm) over time.

Figuras y tablas -
Table 1. Intranasal fentanyl (INF) versus intravenous morphine (IVM)
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Table 2. High concentration intranasal fentanyl (HINF) versus standard concentration intranasal fentanyl (SINF)

SINF

HINF

P value

Before analgesia

80.0 (60.0‐95.5)

77.5 (60.0‐100)

0.881

10 min

49.5 (26.5‐68.5)

43.0 (15.2‐66.0)

0.176

20 min

27.5 (18.5‐56.5)

35.0 (9.0‐57.0)

0.758

30 min

20.0 (10.0‐46.0)

21.5 (4.75‐51.0)

0.662

Borland 2011: Median visual analogue pain score (mm) over time.

Figuras y tablas -
Table 2. High concentration intranasal fentanyl (HINF) versus standard concentration intranasal fentanyl (SINF)
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Table 3. Intranasal fentanyl (INF) versus intramuscular morphine (IMM)

0 min

5 min

10 min

20 min

30 min

Intranasal fentanyl

4

3

1

1

1

Intramuscular morphine

4

3

2

2

1

Younge 1999: Median pain score (Wong Baker Faces, ordinal scoring 0‐5) over time.

Figuras y tablas -
Table 3. Intranasal fentanyl (INF) versus intramuscular morphine (IMM)
Ir a la tabla de la revisión