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Completed

NCT Number: NCT02344368

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

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.

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Key information

Age range

Up to 8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital, Trondheim, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

0.5 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

Primary outcomes

  1. pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Lower Umfolozi Regional War Memorial Hospital
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2015
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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