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

NCT ID: NCT02344368

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.2 ml sucrose

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

Group Type: EXPERIMENTAL

0.2 ml sucrose 25%

Intervention Type: OTHER

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

0.5 ml sucrose 25%

Intervention Type: OTHER

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

0.5 ml sucrose

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

Group Type: EXPERIMENTAL

0.2 ml sucrose 25%

Intervention Type: OTHER

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

0.5 ml sucrose 25%

Intervention Type: OTHER

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

Interventions

0.2 ml sucrose 25%

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

Intervention Type: OTHER

0.5 ml sucrose 25%

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• born preterm
• more than 1000 gram

Exclusion Criteria

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

• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Lower Umfolozi Regional War Memorial Hospital

UNKNOWN

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Håkon Bergseng, MD PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

St Olavs Hospital

Trondheim, , Norway

Lower Umfolozi Rigional War Memorial Hospital, NICU

Empangeni, , South Africa

Countries

Norway; South Africa

References

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.

Reference Type: RESULT

PMID: 30188590 (View on PubMed)

Other Identifiers

2014/2089

Identifier Type: -

Identifier Source: org_study_id