Should an IRB Approve a placebo-controlled randomized trial of analgesia for procedural pain in neonates?

Pediatrics

Volumn 130, Issue 3, 2012, Pages 550-553

  Bellieni, Carlo V ^a   Taddio, Anna ^b   Linebarger, Jenni S ^c   Lantos, John D ^c  

^a UNIVERSITY HOSPITAL OF SIENA   (Italy)

^b UNIVERSITY OF TORONTO   (Canada)

^c UNIVERSITY OF MISSOURI KANSAS CITY SCHOOL OF MEDICINE   (United States)

Author keywords

Pain; Placebo; Randomized trial; Research ethics

Indexed keywords

HYDROCORTISONE; PLACEBO; SUCROSE;

BREAST MILK; COMPARATIVE EFFECTIVENESS; DRUG APPROVAL; HUMAN; INSTITUTIONAL REVIEW; NEWBORN INTENSIVE CARE; PAIN ASSESSMENT; POSTOPERATIVE ANALGESIA; POSTOPERATIVE PAIN; PREMATURE INFANT PAIN PROFILE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SHORT SURVEY;

EID: 84865772589     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2011-2910     Document Type: Short Survey

References (9)

1. Hatfield LA, Chang K, Bittle M, Deluca J, Polomano RC. The analgesic properties of intraoral sucrose: an integrative review. Adv Neonatal Care. 2011;11(2):83-92, quiz 93-94
2. Simons SH, van Dijk M, Anand KS, Roofthooft D, van Lingen RA, Tibboel D. Do we still hurt newborn babies? A prospective study of procedural pain and analgesia in neonates. Arch Pediatr Adolesc Med. 2003;157(11):1058-1064
3. World Medical Association Declaration Of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 59th Assembly of the World Medical Association, Seoul, Korea, 2008. Available at: www.wma.net/en/30publications/10policies/b3/17c.pdf. Accessed June 14, 2012
4. Bellieni CV, Buonocore G. No analgesia to the control group: is it acceptable? Pediatrics. 2010;125(3). Available at: www.pediatrics. org/cgi/content/full/125/3/e709-, author reply e709-e710
5. Anand KJ; International Evidence-Based Group for Neonatal Pain. Consensus statement for the prevention and management of pain in the newborn. Arch Pediatr Adolesc Med. 2001;155(2):173-180
6. Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database of Syst Rev. 2004;(3):CD001069
7. 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;126(5):894-902
8. Losacco V, Cuttini M, Greisen G, et al ESF Network. Heel blood sampling in European neonatal intensive care units: compliance with pain management guidelines. Arch Dis Child Fetal Neonatal Ed. 2011;96(1):F65-F68
9. Stevens BJ, Abbott LK, Yamada J, et al CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011;183(7):E403-E410