Randomized Controlled Trial

. 2018 Feb 23;18(1):85.

doi: 10.1186/s12887-018-1026-x.

The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial

Bonnie Stevens¹, Janet Yamada², Marsha Campbell-Yeo³, Sharyn Gibbins⁴, Denise Harrison⁵, Kimberley Dionne⁶, Anna Taddio⁷, Carol McNair⁶, Andrew Willan⁸, Marilyn Ballantyne⁹, Kimberley Widger¹⁰, Souraya Sidani², Carole Estabrooks¹¹, Anne Synnes¹², Janet Squires¹³, Charles Victor¹⁴, Shirine Riahi⁶

Affiliations

¹ The Hospital for Sick Children, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada. bonnie.stevens@sickkids.ca.
² Daphne Cockwell School of Nursing, Ryerson University, 350 Victoria Street, Toronto, Ontario, M5B 2K3, Canada.
³ School of Nursing and Departments of Pediatrics, Psychology, and Neuroscience, Dalhousie University, IWK Health Centre, Forrest Building, P.O. Box 15000, Halifax, Nova Scotia, B3H 4R2, Canada.
⁴ Trillium Health Partners, 100 Queensway West, Mississauga, Ontario, L5B 1B8, Canada.
⁵ Faculty of Health Sciences, School of Nursing, University of Ottawa, Children's Hospital of Eastern Ontario, Research Institute, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada.
⁶ The Hospital for Sick Children, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.
⁷ The Hospital for Sick Children, Leslie Dan Faculty of Pharmacy, University of Toronto, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.
⁸ The Hospital for Sick Children, Dalla Lana School of Public Health, University of Toronto, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.
⁹ Holland Bloorview Kids Rehabilitation Hospital, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 150 Kilgour Road, Toronto, Ontario, M4G 1R8, Canada.
¹⁰ The Hospital for Sick Children, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, Ontario, M5T 1P8, Canada.
¹¹ Faculty of Nursing, University of Alberta, 3-141 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.
¹² Division of Neonatology, Department of Pediatrics, University of British Columbia, 2D19-4480 Oak Street, Vancouver, British Columbia, V6H 4V4, Canada.
¹³ Faculty of Health Sciences, School of Nursing, University of Ottawa, Ottawa Hospital Research Institute, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada.
¹⁴ Institute for Clinical Evaluative Sciences (ICES), The Institute of Health Policy, Management and Evaluation, University of Toronto, Veterans Hill Trail, 2075 Bayview Avenue G1 06, Toronto, Ontario, M4N 3M5, Canada.

PMID: 29475433
PMCID: PMC5824554
DOI: 10.1186/s12887-018-1026-x

Randomized Controlled Trial

The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial

Bonnie Stevens et al. BMC Pediatr. 2018.

. 2018 Feb 23;18(1):85.

doi: 10.1186/s12887-018-1026-x.

Authors

Affiliations

¹ The Hospital for Sick Children, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada. bonnie.stevens@sickkids.ca.
² Daphne Cockwell School of Nursing, Ryerson University, 350 Victoria Street, Toronto, Ontario, M5B 2K3, Canada.
³ School of Nursing and Departments of Pediatrics, Psychology, and Neuroscience, Dalhousie University, IWK Health Centre, Forrest Building, P.O. Box 15000, Halifax, Nova Scotia, B3H 4R2, Canada.
⁴ Trillium Health Partners, 100 Queensway West, Mississauga, Ontario, L5B 1B8, Canada.
⁵ Faculty of Health Sciences, School of Nursing, University of Ottawa, Children's Hospital of Eastern Ontario, Research Institute, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada.
⁶ The Hospital for Sick Children, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.
⁷ The Hospital for Sick Children, Leslie Dan Faculty of Pharmacy, University of Toronto, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.
⁸ The Hospital for Sick Children, Dalla Lana School of Public Health, University of Toronto, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.
⁹ Holland Bloorview Kids Rehabilitation Hospital, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 150 Kilgour Road, Toronto, Ontario, M4G 1R8, Canada.
¹⁰ The Hospital for Sick Children, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, Ontario, M5T 1P8, Canada.
¹¹ Faculty of Nursing, University of Alberta, 3-141 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.
¹² Division of Neonatology, Department of Pediatrics, University of British Columbia, 2D19-4480 Oak Street, Vancouver, British Columbia, V6H 4V4, Canada.
¹³ Faculty of Health Sciences, School of Nursing, University of Ottawa, Ottawa Hospital Research Institute, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada.
¹⁴ Institute for Clinical Evaluative Sciences (ICES), The Institute of Health Policy, Management and Evaluation, University of Toronto, Veterans Hill Trail, 2075 Bayview Avenue G1 06, Toronto, Ontario, M4N 3M5, Canada.

PMID: 29475433
PMCID: PMC5824554
DOI: 10.1186/s12887-018-1026-x

Abstract

Background: Orally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure.

Methods: A total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups.

Results: There was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention.

Conclusions: The minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted.

Trial registration: ClinicalTrials.gov : NCT02134873. Date: May 5, 2014 (retrospectively registered).

Keywords: Adverse event; Analgesia; Heel lance; NICU; Neonates; PIPP-R; Pain; Preterm infants; Sucrose.

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Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the Research Ethics Boards at The Hospital for Sick Children (1000038052), Sunnybrook Health Sciences Centre (354–2013), IWK Health Centre (1013855), The Ottawa Hospital (20130327-01H), and Children’s Hospital of Eastern Ontario (13/12E). Informed written consent was obtained from a parent prior to study enrollment.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
Consort flow diagram of all neonates in participating NICUs screened for eligibility and randomized to sucrose intervention groups. Reasons for exclusion included not meeting inclusion criteria, refusals to participate, and other reasons [e.g., exclusion criteria, medical refusal (palliative care, social issues, and multiple research studies), isolation precautions, and researcher or parents unavailable for consent discussion]

See this image and copyright information in PMC

References

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1. Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016;7(7):CD001069. - PMC - PubMed
1. Lee GY, Yamada J, Kyololo O, Shorkey A, Stevens B. Pediatric clinical practice guidelines for acute procedural pain: a systematic review. Pediatrics. 2014;133(3):500–515. doi: 10.1542/peds.2013-2744. - DOI - PubMed
1. Taddio A, Yiu A, Smith RW, Katz J, McNair C, Shah V. Variability in clinical practice guidelines for sweetening agents in newborn infants undergoing painful procedures. Clin J Pain. 2009;25(2):153–155. doi: 10.1097/AJP.0b013e3181847a09. - DOI - PubMed
1. Bellieni CV, Johnston CC. Analgesia, nil or placebo to babies, in trials that test new analgesic treatments for procedural pain. Acta Paediatr. 2016;105(2):129–136. doi: 10.1111/apa.13210. - DOI - PubMed

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The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial

Affiliations

The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical