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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: 0.2 ml sucrose 25%; Other: 0.5 ml sucrose 25%

• Registration Number: NCT02344368
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-26
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0.2 ml sucrose	0.2 ml sucrose 25%	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
0.2 ml sucrose	0.5 ml sucrose 25%	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
0.5 ml sucrose	0.2 ml sucrose 25%	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
0.5 ml sucrose	0.5 ml sucrose 25%	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

Primary Outcome Measures

Name	Time	Method
pain	1 week	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

Trial Locations

Locations (2)

Lower Umfolozi Rigional War Memorial Hospital, NICU; 🇿🇦 Empangeni, South Africa

St Olavs Hospital; 🇳🇴 Trondheim, Norway