Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
230 participants
OBSERVATIONAL
2010-06-30
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain
NCT01503060
Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
NCT00150189
Sucking and Sucrose as Pain Relief for Infants
NCT00805623
Analgesic Properties of Oral Sucrose During Immunizations
NCT00446875
A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization
NCT01601197
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Infants meeting inclusion criteria were identified daily by reviewing the list of patients scheduled for a 2 or 4 month well child visit at the outpatient site. The parent or legal guardian was approached prior to vaccination by the research assistant for participation in the study. If the parent/guardian accepted to participate in the vaccine study, the consenting process was performed and patients were brought to a designated examination room. Infants of parents or guardians who consented were randomly assigned to one of four study groups using pre-sealed cards. Ten cards were assigned to each group for a total of 40 cards, which were recycled with each group of 40 infants enrolled into the study. The four groups of the study included:
1. 2 ml of water 2 minutes prior to immunization and comfort by parent or guardian after Immunization (Control Group)
2. 2 ml of 24% oral sucrose 2 minutes prior to immunization and comfort by parent or guardian after immunization (Sucrose Group)
3. 2 ml of water 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical Group)
4. 2 ml of 24% oral sucrose 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical and Sucrose Group)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control
water and normal physical comfort provided by mom
No interventions assigned to this group
sucrose
sugar and normal physical comfort provided by mom
No interventions assigned to this group
physical intervention
physical intervention using the 5 S's and water
No interventions assigned to this group
physical intervention and sucrose
Physical intervention using the 5 S's and sugar water
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2 Months
4 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Hospital of The King's Daughters
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
John Harrington
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John W Harrington, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of The King's Daughters
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ornstein PA, Manning EL, Pelphrey KA. Children's memory for pain. J Dev Behav Pediatr. 1999 Aug;20(4):262-77. doi: 10.1097/00004703-199908000-00009.
Taddio A, Shah V, Atenafu E, Katz J. Influence of repeated painful procedures and sucrose analgesia on the development of hyperalgesia in newborn infants. Pain. 2009 Jul;144(1-2):43-8. doi: 10.1016/j.pain.2009.02.012. Epub 2009 Mar 28.
Jacobson RM, Swan A, Adegbenro A, Ludington SL, Wollan PC, Poland GA; Vaccine Research Group. Making vaccines more acceptable--methods to prevent and minimize pain and other common adverse events associated with vaccines. Vaccine. 2001 Mar 21;19(17-19):2418-27. doi: 10.1016/s0264-410x(00)00466-7.
Reis EC. Multiple scheduled injections contribute to missed opportunities to immunize during well care visits. Ambul Child Health 1997;3:172
Woodin KA, Rodewald LE, Humiston SG, Carges MS, Schaffer SJ, Szilagyi PG. Physician and parent opinions. Are children becoming pincushions from immunizations? Arch Pediatr Adolesc Med. 1995 Aug;149(8):845-9. doi: 10.1001/archpedi.1995.02170210019003.
Shah V, Taddio A, Ohlsson A. Randomised controlled trial of paracetamol for heel prick pain in neonates. Arch Dis Child Fetal Neonatal Ed. 1998 Nov;79(3):F209-11. doi: 10.1136/fn.79.3.f209.
Howard CR, Howard FM, Weitzman ML. Acetaminophen analgesia in neonatal circumcision: the effect on pain. Pediatrics. 1994 Apr;93(4):641-6.
Taddio A, Manley J, Potash L, Ipp M, Sgro M, Shah V. Routine immunization practices: use of topical anesthetics and oral analgesics. Pediatrics. 2007 Sep;120(3):e637-43. doi: 10.1542/peds.2006-3351.
Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50. doi: 10.1016/S0140-6736(09)61208-3.
Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. doi: 10.1002/14651858.CD001069.pub3.
Harrison D, Bueno M, Yamada J, Adams-Webber T, Stevens B. Analgesic effects of sweet-tasting solutions for infants: current state of equipoise. Pediatrics. 2010 Nov;126(5):894-902. doi: 10.1542/peds.2010-1593. Epub 2010 Oct 11.
Bo LK, Callaghan P. Soothing pain-elicited distress in Chinese neonates. Pediatrics. 2000 Apr;105(4):E49. doi: 10.1542/peds.105.4.e49.
Field T, Goldson E. Pacifying effects of nonnutritive sucking on term and preterm neonates during heelstick procedures. Pediatrics. 1984 Dec;74(6):1012-5.
Leite AM, Linhares MB, Lander J, Castral TC, dos Santos CB, Silvan Scochi CG. Effects of breastfeeding on pain relief in full-term newborns. Clin J Pain. 2009 Nov-Dec;25(9):827-32. doi: 10.1097/AJP.0b013e3181b51191.
Gray L, Miller LW, Philipp BL, Blass EM. Breastfeeding is analgesic in healthy newborns. Pediatrics. 2002 Apr;109(4):590-3. doi: 10.1542/peds.109.4.590.
Gray L, Watt L, Blass EM. Skin-to-skin contact is analgesic in healthy newborns. Pediatrics. 2000 Jan;105(1):e14. doi: 10.1542/peds.105.1.e14.
Prasopkittikun T, Tilokskulchai F. Management of pain from heel stick in neonates: an analysis of research conducted in Thailand. J Perinat Neonatal Nurs. 2003 Oct-Nov;17(4):304-12. doi: 10.1097/00005237-200310000-00009.
Campos RG. Soothing pain-elicited distress in infants with swaddling and pacifiers. Child Dev. 1989 Aug;60(4):781-92.
O'Sullivan A, O'Connor M, Brosnahan D, McCreery K, Dempsey EM. Sweeten, soother and swaddle for retinopathy of prematurity screening: a randomised placebo controlled trial. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F419-22. doi: 10.1136/adc.2009.180943. Epub 2010 Sep 28.
Karp, Harvey. The Happiest Baby on the Block. New York, NY: Bantam Books; 2003
Taddio A, Ilersich AL, Ipp M, Kikuta A, Shah V; HELPinKIDS Team. Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations: systematic review of randomized controlled trials and quasi-randomized controlled trials. Clin Ther. 2009;31 Suppl 2:S48-76. doi: 10.1016/j.clinthera.2009.07.024.
Schade JG, Joyce BA, Gerkensmeyer J, Keck JF. Comparison of three preverbal scales for postoperative pain assessment in a diverse pediatric sample. J Pain Symptom Manage. 1996 Dec;12(6):348-59. doi: 10.1016/s0885-3924(96)00182-0.
McGrath PA. Pain in Children: Nature, Assessment, and Treatment. New York, NY:Guilford Press;1990.
Blass EM. Milk-induced hypoalgesia in human newborns. Pediatrics. 1997 Jun;99(6):825-9. doi: 10.1542/peds.99.6.825.
Liu Y, von Deneen KM, Kobeissy FH, Gold MS. Food addiction and obesity: evidence from bench to bedside. J Psychoactive Drugs. 2010 Jun;42(2):133-45. doi: 10.1080/02791072.2010.10400686.
Berthoud HR, Lenard NR, Shin AC. Food reward, hyperphagia, and obesity. Am J Physiol Regul Integr Comp Physiol. 2011 Jun;300(6):R1266-77. doi: 10.1152/ajpregu.00028.2011. Epub 2011 Mar 16.
Stice E, Yokum S, Burger KS, Epstein LH, Small DM. Youth at risk for obesity show greater activation of striatal and somatosensory regions to food. J Neurosci. 2011 Mar 23;31(12):4360-6. doi: 10.1523/JNEUROSCI.6604-10.2011.
Pickering, LK, ed. RedBook: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009
Tuck RH. Coding and payment for immunizations. Pediatr Ann. 2006 Jul;35(7):507-12. doi: 10.3928/0090-4481-20060701-07.
Harrington JW, Logan S, Harwell C, Gardner J, Swingle J, McGuire E, Santos R. Effective analgesia using physical interventions for infant immunizations. Pediatrics. 2012 May;129(5):815-22. doi: 10.1542/peds.2011-1607. Epub 2012 Apr 16.
Related Links
Access external resources that provide additional context or updates about the study.
Demonstration of the 5 S's
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EVMS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.