The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants

NCT02344368 | Completed

• 1 other identifier: 2014/2089
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief Summary

Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. The aim of this study is to find the minimal effective dose of sucrose to reduce pain during a single venous blood sampling procedure.

Conditions

Pain

Keywords

Sucrose; Anesthesia; Blood specimen collection; Injections, Intravenous

Outcome Measures

Primary Outcomes (1)

• pain

  assessed by Premature Infant Pain Profile-Revised (PIPP-R). Pain score related to the blood sampling will be performed two times: at skin puncture and immediately after the needle has been removed

  1 week

Study Arms (2)

0.2 ml sucrose

EXPERIMENTAL

on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling

Other: 0.2 ml sucrose 25%; Other: 0.5 ml sucrose 25%

0.5 ml sucrose

EXPERIMENTAL

on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling

Other: 0.2 ml sucrose 25%; Other: 0.5 ml sucrose 25%

Interventions

0.2 ml sucrose 25% OTHER

Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling

0.2 ml sucrose; 0.5 ml sucrose

0.5 ml sucrose 25% OTHER

Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling

0.2 ml sucrose; 0.5 ml sucrose

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• born preterm
• more than 1000 gram

You may not qualify if:

• severe intraventricular hemorrhage
• cerebral malformations
• other malformations requiring surgery
• medication that may impair pain expression (opioids, paracetamol, sedatives)

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Lower Umfolozi Regional War Memorial Hospital: collaborator

Study Sites (2)

St Olavs Hospital

Trondheim, Norway

Location

Lower Umfolozi Rigional War Memorial Hospital, NICU

Empangeni, South Africa

Location

Related Publications (1)

• Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Stoen R, Follestad T, Eik-Nes SH, Bergseng H. Randomised controlled trial showed that neonates received better pain relief from a higher dose of sucrose during venepuncture. Acta Paediatr. 2018 Dec;107(12):2071-2078. doi: 10.1111/apa.14567. Epub 2018 Oct 2.

  PMID: 30188590 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Håkon Bergseng, MD PhD

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 26, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 4, 2020

Record last verified: 2016-07

Locations

ZA (1); NO (1)