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Use of Sucrose to Relieve Pain During Eye Exams in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161694
Recruitment Status : Terminated (results did not show intervention was beneficial)
First Posted : September 12, 2005
Last Update Posted : June 4, 2008
Information provided by:
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Apnea of Prematurity Retinopathy of Prematurity Pain Dietary Supplement: sucrose solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effectiveness of an Oral Sucrose Solution in Reducing Pain and Anxiety Associated With Neonatal Ophthalmologic Examination
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00161694

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United States, New York
NYPH - Weill Cornell Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
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Principal Investigator: Tamara L Rousseau, MD Neonatology Fellow at NYPH-Weill Cornell Medical Center
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.

Layout table for additonal information Identifier: NCT00161694    
Other Study ID Numbers: 0412007634
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by Weill Medical College of Cornell University:
pain control
Additional relevant MeSH terms:
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Retinopathy of Prematurity
Premature Birth
Retinal Diseases
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases