The pediatric surgery outpatient population has grown extensively in recent years. Tonsillectomy, one of the most prevalent ambulatory surgeries in children, has been associated with a substantial degree of postoperative morbidity, with inadequate pain control cited as a major concern. Therefore, this randomized clinical trial will compare the effectiveness of a structured pain management program (i.e. that combines routine parent postoperative education, with around the clock (ATC) dosing of analgesics and nurse coaching, that is targeted at decreasing barriers to effective pain control in the home), with either standard care (i.e. routine parent postoperative education) and """"""""as needed"""""""" analgesic dosing, or standard care and ATC dosing. Patients (N = 300) will be recruited from a large ambulatory surgery program and will be randomized to one of three treatment groups. Parents in the standard care groups will receive routine postoperative education and will be told to administer pain medication to their children every 4 hours """"""""as needed"""""""" (Group A), or every 4 hours ATC (Group B). Parents in the structured pain management group (Group C) will receive and educational session that includes standard postoperative instructions and pain management education targeted at increasing knowledge and decreasing barriers to effective pain management as part of a coaching intervention, and will told to administer pain medication every four hours ATC. Parents in all three groups will receive follow-up phone calls on days 1 and 2 following surgery. In the standard care groups, the purpose of the phone calls will be to ascertain level of adherence with completion of the daily logs. Parents in the structured pain management group will receive coaching during the phone calls to include review of pain scores, child adherence to taking pain medicine, strategies for pain medication administration (as indicated), rationale for ATC dosing and instruction for ATC dosing, and potential side effects. Patients will be followed for three days and nights following tonsillectomy and parents will complete diaries in the morning and in the evening. The major outcome variables for this study are: pain intensity scores with and without swallowing, analgesic consumption, oral intake of fluids, negative behaviors and side effects. Patients and parents in all pain management groups will have and end of study interview to describe their experiences with the program.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR004826-03
Application #
6530943
Study Section
Nursing Research Study Section (NURS)
Program Officer
Hare, Martha L
Project Start
2000-06-01
Project End
2004-02-29
Budget Start
2002-03-01
Budget End
2003-02-28
Support Year
3
Fiscal Year
2002
Total Cost
$307,451
Indirect Cost
Name
University of California San Francisco
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Sutters, Kimberly A; Holdridge-Zeuner, Danielle; Waite, Steven et al. (2012) A descriptive feasibility study to evaluate scheduled oral analgesic dosing at home for the management of postoperative pain in preschool children following tonsillectomy. Pain Med 13:472-83
Sutters, Kimberly A; Savedra, Marilyn C; Miaskowski, Christine (2011) The pediatric PRO-SELF©: pain control program: an effective educational program for parents caring for children at home following tonsillectomy. J Spec Pediatr Nurs 16:280-94
(2011) Commentary on ""Letter to the Editor for article titled A Randomized Clinical Trial of the Efficacy of Scheduled Dosing of Acetaminophen and Hydrocodone for the Management of Postoperative Pain in Children After Tonsillectomy"" Clin J Pain 27:90-91
Sutters, Kimberly A; Miaskowski, Christine; Holdridge-Zeuner, Danielle et al. (2010) A randomized clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after tonsillectomy. Clin J Pain 26:95-103
Sutters, Kimberly A; Savedra, Marilyn C; Miaskowski, Christine et al. (2007) Children's expectations of pain, perceptions of analgesic efficacy, and experiences with nonpharmacologic pain management strategies at home following tonsillectomy. J Spec Pediatr Nurs 12:139-48
Sutters, Kimberly A; Miaskowski, Christine; Holdridge-Zeuner, Danielle et al. (2005) Time-contingent dosing of an opioid analgesic after tonsillectomy does not increase moderate-to-severe side effects in children. Pain Manag Nurs 6:49-57