Use of Sucrose to Relieve Pain During Eye Exams in Infants

NCT00161694 | Terminated

• 1 other identifier: 0412007634
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea of Prematurity; Retinopathy of Prematurity; Pain

Keywords

pain control

Interventions

sucrose solution DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 5 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

NYPH - Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Apnea; Retinopathy of Prematurity; Pain; Agnosia

Interventions

sodium lactobionate sucrose solution

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Tamara L Rousseau, MD

  Neonatology Fellow at NYPH-Weill Cornell Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2005
• Last Updated: June 4, 2008

Record last verified: 2008-06

Locations

US (1)