Use of Sucrose to Relieve Pain During Eye Exams in Infants - Full Text View

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00161694

Purpose

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	Intervention
Apnea of Prematurity Retinopathy of Prematurity Pain	Dietary Supplement: sucrose solution

MedlinePlus related topics: Retinal Disorders

Drug Information available for: Sucrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effectiveness of an Oral Sucrose Solution in Reducing Pain and Anxiety Associated With Neonatal Ophthalmologic Examination

Further study details as provided by Weill Medical College of Cornell University:

Estimated Enrollment:	300
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	5 Weeks and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161694

Locations

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

Investigators

Principal Investigator:

Tamara L Rousseau, MD

Neonatology Fellow at NYPH-Weill Cornell Medical Center

More Information

Publications:

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.

Study ID Numbers:	0412007634
Study First Received:	September 8, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00161694
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

pain control

Study placed in the following topic categories:

Apnea
Eye Diseases
Retinopathy of prematurity
Infant, Newborn, Diseases

Infant, Premature, Diseases
Retinopathy of Prematurity
Pain
Retinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009