Sucrose Practices for Pain in Neonates

NCT02134873 | Completed DMC

• 1 other identifier: 1000038052
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing pain during invasive procedures and is a standard of care for painful procedures. The purpose of this study is to see what is the least amount of sucrose that can be given to a baby to reduce pain during procedures.

Conditions

Pain

Keywords

Pain; Pain management; Hospitalized; Infants; Sucrose

Outcome Measures

Primary Outcomes (1)

• The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R).

  Premature Infant Pain Profile- Revised is a validated pain measure to assess infant pain

  Change from baseline 30 seconds post painful procedure

Secondary Outcomes (2)

• The secondary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R).

  Change from baseline 60 seconds post painful procedure

• The secondary outcome is frequency of occurrence of adverse events.

  Starting from the administration of sucrose until the end of the procedure (procedure could last on average 6 minutes) or longer if indicated.

Study Arms (6)

0.1ml 24% sucrose concurrent opioids

ACTIVE COMPARATOR

0.1ml 24% sucrose concurrent opioids

Other: sucrose

0.5ml 24% sucrose concurrent opioids

ACTIVE COMPARATOR

0.5ml 24% sucrose concurrent opioids

Other: sucrose

1.0ml 24% sucrose concurrent opioids

ACTIVE COMPARATOR

1.0ml 24% sucrose concurrent opioids

Other: sucrose

0.1ml 24% sucrose no opioids

ACTIVE COMPARATOR

0.1ml 24% sucrose no opioids

Other: sucrose

0.5ml 24% sucrose no opioids

ACTIVE COMPARATOR

0.5ml 24% sucrose no opioids

Other: sucrose

1.0ml 24% sucrose no opioids

ACTIVE COMPARATOR

1.0ml 24% sucrose no opioids

Other: sucrose

Interventions

sucrose OTHER

Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.

Also known as: Brand name = Tootsweet

0.1ml 24% sucrose concurrent opioids; 0.1ml 24% sucrose no opioids; 0.5ml 24% sucrose concurrent opioids; 0.5ml 24% sucrose no opioids; 1.0ml 24% sucrose concurrent opioids; 1.0ml 24% sucrose no opioids

Eligibility Criteria

• Age: 1 Day - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants 24 to 42 weeks gestational age (GA) at birth, admitted to the Neonatal Intensive Care Unit (NICU), and scheduled to receive a heel lance will be eligible. Parents will be approached for participation within the first 2 weeks of the infant's life. Infants will be eligible for Trial 1, the non-opioid trial, if they have not received any opioids within 24 hours prior to the heel lance. Infants will be eligible for Trial 2, the opioid trial, if they are currently receiving an opioid infusion. Furthermore, observation of the procedures will be timed to ensure that no additional sucrose doses are provided within the previous 4 hours.

You may not qualify if:

• Infants will be excluded if they have a contraindication for sucrose administration (e.g., unable to swallow, pharmacologically muscle relaxed, or heavily sedated) due to safety concerns and/or inability to assess pain accurately (e.g., unable to clearly view the infant's face).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Stevens B, Yamada J, Campbell-Yeo M, Gibbins S, Harrison D, Dionne K, Taddio A, McNair C, Willan A, Ballantyne M, Widger K, Sidani S, Estabrooks C, Synnes A, Squires J, Victor C, Riahi S. The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial. BMC Pediatr. 2018 Feb 23;18(1):85. doi: 10.1186/s12887-018-1026-x.

  PMID: 29475433 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Bonnie Stevens, RN, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Bonnie Stevens, RN, PhD, Signy Hildur Eaton Chair in Paediatric Nursing Research, Associate Chief of Nursing Research

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 9, 2014
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

CA (1)