A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED TRIAL EXAMINING THE ANALGESIC PROPERTIES OF ORAL SUCROSE DURING ROUTINE IMMUNIZATIONS AT TWO AND FOUR MONTHS OF AGE
Open Access
- Author:
- Hatfield, Linda Antoinette
- Graduate Program:
- Nursing
- Degree:
- Doctor of Philosophy
- Document Type:
- Dissertation
- Date of Defense:
- March 21, 2006
- Committee Members:
- Judith E Hupcey, Committee Chair/Co-Chair
Mary Beth Clark, Committee Member
Vernon Michael Chinchilli, Committee Member
Cheston Milton Berlin, Committee Member - Keywords:
- pain
pediatric pain
infant
newborn
nociception
neonatal - Abstract:
- The purpose of this study is to evaluate the effectiveness of and age-related changes in analgesia of oral sucrose as a pre-procedural intervention for acute pain during routine immunizations at two and four months of age. Melzack and Wall’s (1965) gate control theory of pain served as the theoretical frame guiding this prospective, parent and investigator- masked, randomized, clinical trial. Forty healthy term infants receiving their routine two or 4-month immunizations at Penn State Milton S. Hershey Medical Center’s ambulatory pediatric clinic were sampled. Infants were randomized to the treatment group (24% sucrose, n=20) or the control group (sterile water, n=20). Infants’ study participation was at their two and four-month well-child visit. Treatment intervention was administered two minutes before the three serial routine immunizations. The University of Wisconsin Children’s Hospital pain scale measured infant behavioral pain response for the treatment and control group at baseline, two, and five minutes following solution administration. A two by two repeated measures ANOVA examined the effects of treatment conditions and age on pain assessment scores. Comparisons of change in behavioral pain response between two and four months of age were not statistically significant at two minutes and five minutes following treatment administration (p-value=1.00). Age groups were combined within treatment, to test for a difference in change in behavioral pain response between treatment and control groups at two minutes and five minutes following treatment administration. Change in pain response from baseline to two minutes following treatment administration was not statistically significant (p-value=0.958). Between the treatment and control group the change in behavioral pain response from baseline to five minutes following treatment administration was statistically significant (p<0.0001). The effect of gender (p=0.1865), nutrition (p=0.8096), prior painful experiences (p=0.2159) and analgesia (p=0.2266) on behavioral pain response were statistically non-significant. Immunizations constitute a necessary preventive health measure in pediatric clinics. Since healthy newborns’ behavioral pain response is increased after immunizations, it is reasonable to develop practical clinical interventions to promote comfort and alleviate their pain and distress. Sucrose is an effective pre-procedure intervention for decreasing behavior pain response after immunizations at two and four months of age.