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

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ClinicalTrials.gov Identifier: NCT02344368
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
St. Olavs Hospital
Lower Umfolozi Regional War Memorial Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Other: 0.2 ml sucrose 25% Other: 0.5 ml sucrose 25% Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 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

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
Experimental: 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
 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

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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344368


Locations
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Norway
St Olavs Hospital
Trondheim, Norway
South Africa
Lower Umfolozi Rigional War Memorial Hospital, NICU
Empangeni, South Africa
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Lower Umfolozi Regional War Memorial Hospital
Investigators
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Study Director: Håkon Bergseng, MD PhD Norwegian University of Science and Technology
More Information
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Publications of Results:

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02344368    
Other Study ID Numbers: 2014/2089
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: July 2016
Keywords provided by Norwegian University of Science and Technology:
Sucrose
Anesthesia
Blood specimen collection
Injections, Intravenous