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Use of Sucrose to Relieve Pain During Eye Exams in Infants

Primary Purpose

Apnea of Prematurity, Retinopathy of Prematurity, Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sucrose solution
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Apnea of Prematurity focused on measuring pain control

Eligibility Criteria

5 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All premature infants admitted to the Neonatal Intensive Care Unit requiring serial dilated examinations to assess for retinopathy of prematurity will be candidates for this study. This includes all infants with a birthweight of less than 1500 g and infants between 1500 g and 2000 g who require supplemental oxygen. Exclusion Criteria: Any infant who is unable to safely suckle 0.5 cc of fluid will be excluded from the study. This includes infants that are being maintained on ventilators and those with serious gastrointestinal complications that may be exacerbated by an oral fluid bolus. Any infant being maintained on narcotics for any reason will not be eligible for the study. All infants with major congenital anomalies will be excluded.

Sites / Locations

  • NYPH - Weill Cornell Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
June 2, 2008
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00161694
Brief Title
Use of Sucrose to Relieve Pain During Eye Exams in Infants
Official Title
Effectiveness of an Oral Sucrose Solution in Reducing Pain and Anxiety Associated With Neonatal Ophthalmologic Examination
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
results did not show intervention was beneficial
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. The investigators believe that the use of this solution prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate and a fall in oxygen saturation. In addition this will lead to a decrease in events in the 12 hours following examination. Events include episodes when the infants temporarily stop breathing, have a drop in their heart rates, or have a drop in their oxygen levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity, Retinopathy of Prematurity, Pain
Keywords
pain control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
sucrose solution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All premature infants admitted to the Neonatal Intensive Care Unit requiring serial dilated examinations to assess for retinopathy of prematurity will be candidates for this study. This includes all infants with a birthweight of less than 1500 g and infants between 1500 g and 2000 g who require supplemental oxygen. Exclusion Criteria: Any infant who is unable to safely suckle 0.5 cc of fluid will be excluded from the study. This includes infants that are being maintained on ventilators and those with serious gastrointestinal complications that may be exacerbated by an oral fluid bolus. Any infant being maintained on narcotics for any reason will not be eligible for the study. All infants with major congenital anomalies will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara L Rousseau, MD
Organizational Affiliation
Neonatology Fellow at NYPH-Weill Cornell Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYPH - Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
Citation
1 American Academy of Pediatrics: screening Examination of Premature Infants for Retinopathy of Prematurity. Pediatrics 2001;108:809-811. 2 Laws DE,C Morton, MWeindling, D Clark. Systemic effects of screening for retinopathy of prematurity. Br J Opthalmol 1996;80:425-428. 3 Kumar H, S Naniwal, USingha, E Azad, VK Paul. Stress induced by screening for retinopathy of prematurity. J Pediatr Opthalmology and Strabismus. 2002;39:349-350. 4 Aguirre Rodriguez FJ, A Bonilla Perales, J Diez-Delgado Rubio, M Gonzales-Ripoll Garzon, J Arcos Martinez, J Lopez Munoz. An Pediatr (Barc) 2003;58:504-505. 5 Slevin M, JFA Murphy, L Daly, m o'Keefe. Retinopathy of prematurity screening, stress related response, the role of nesting. Br J Opthalmol 1997;81:762-764. 6 Als H, G Lawhon, E Brown et al. Individualized behavior and environmental care for the VLBW preterm infant at high risk for BPD: NICU and developmental outcome. Pediatrics 1986;78:1123-1132. 7 Stevens B, J Yamada, A Ohlsson. Sucrose for analgesia in newborn infants undergoing painful procedures (Cochrane Review). In The Cochrane Library, Issue 1, 2004. 8 Benis MM. Efficacy of sucrose analgesia for procedural pain in neonates. Dv Neonatal Care. 2002;2:93-100. 9 Masters-Harte LD. Sucrose analgesia for minor procedures in newborn infants. Ann Pharmacother 2001;35:947-952. 10 Akman I, EOzek, H Bilgen, T Ozgodan, D Cebeci. Sweet solutions and pacifiers for pain relief in newborn infants. The Journal of Pain 2002:3. 11 Blass EM. Behavioral and physiological consequences of suckling in rat and human newborns. Acta Paediatr Suppl 1994;397:71-76. 12 Campos RG. Soothing pain-elicited distress in infants with swaddling and pacifiers. Child Dev 1989;60:781-792. 13 Blass EM. Suckling and sucrose-induced analgesia in human newborns. Pain 1999;83:611-623. 14 Carbajal R, R Lenclen, V Gadjos, M Jugic, A Paupe. Crossover trial of analgesic efficacy of glucose and pacifier in very preterm neonates during subcutaneous injections. Pediatrics 2002;110:389-393. 15 Blass EM. Milk induced hypoalgesia in human newborns. Pediatrics 1997;99:825-829. 16 Carbajal R, S Veerapen, S Coulder, M Jugie, Y Ville. Analgesic effect of breast-feeding in term neonates: randomized controlled trial. British Medical Journal 2003;326:13. 17 Guala A. Glucose or sucrose as an analgesic for newborns: a randomized controlled blind trial. Minerva Pediatr 2001;53:271-274. 18 Anseloni VC. Age-dependency of analgesia elicited by intraoral sucrose in acute and persistent pain models. Pain 2002;97:93-103. 19 Willis D, J Chabot, I Radde, G Chance. Unsuspected hyperosmolality of oral solutions contributing to necrotizing enterocolitis in very-low-birth-weight infants. Pediatrics 1997;60:535-538. 20 American Academy of Pediatrics. Prevention and Management of Pain and Stress in the Neonate. Pediatrics 2000;105:454-461. 21 Morison S, R Grunau, T Oberlander, F Tim, M Whitfield. Relations between behavioral and cardiac autonomic reactivity to acute pain in preterm neonates. Clinical Journal of Pain 2001;17:350-358.
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Use of Sucrose to Relieve Pain During Eye Exams in Infants

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