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

Pain Clinical Trial

Official title:

The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344368
• Other study ID #: 2014/2089
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim
South Africa	Lower Umfolozi Rigional War Memorial Hospital, NICU	Empangeni

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Lower Umfolozi Regional War Memorial Hospital, St. Olavs Hospital

Countries where clinical trial is conducted

Norway,  South Africa, 

References & Publications (1)

Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Støen 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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