Tonsillectomy Clinical Trial
Official title:
Home Care Management of Pediatric Pain
Verified date | June 2012 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to determine whether around-the-clock dosing of pain medication, with or without nurse coaching, increases the effectiveness of pain management (i.e., decreased pain intensity scores with and without swallowing, increased use of pain medication, improved sleep, increased oral intake of fluids, decreased negative behaviors, and the same degree of side effects), over time, compared to standard care with "as needed" dosing.
Status | Completed |
Enrollment | 211 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 15 Years |
Eligibility |
Inclusion Criteria: - Outpatient tonsillectomy, with or without other minor procedures (e.g., ear tube placement); parental consent; child assent (age-appropriate); ability of the child to speak English; ability of the parents to read, write, and speak English; and, access to a telephone. Exclusion Criteria: - History of severe obstructive sleep apnea (causing the child to stop breathing repeatedly during sleep); known problems with vision, hearing, control and coordination of movement, or thinking ability. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Central California | Madera | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Institute of Nursing Research (NINR) |
United States,
Sutters KA, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B, Mahoney K, Miaskowski C. 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. 2012 Mar;13(3):472-83. doi: 10.1111/j.1526-4637.2011.01324.x. Epub 2012 Feb 7. — View Citation
Sutters KA, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B, Mahoney K. A randomized clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after to — View Citation
Sutters KA, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B. A randomized clinical trial of the effectiveness of a scheduled oral analgesic dosing regimen for the management of postoperative pain in children following tonsillectomy. Pain. 2004 Jul;110(1-2):49-55. — View Citation
Sutters KA, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B. Time-contingent dosing of an opioid analgesic after tonsillectomy does not increase moderate-to-severe side effects in children. Pain Manag Nurs. 2005 Jun;6(2):49-57. — View Citation
Sutters KA, Savedra MC, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Lanier B. Children's expectations of pain, perceptions of analgesic efficacy, and experiences with nonpharmacologic pain management strategies at home following tonsillectomy. J Spec Pediatr Nurs. 2007 Jul;12(3):139-48. — View Citation
Sutters KA, Savedra MC, Miaskowski C. The pediatric PRO-SELF©: pain control program: an effective educational program for parents caring for children at home following tonsillectomy. J Spec Pediatr Nurs. 2011 Oct;16(4):280-94. doi: 10.1111/j.1744-6155.201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the effectiveness of pain management "over time", compared to standard care with "as needed" dosing. | Morning and evening for 3 days following surgery | No | |
Secondary | Pain intensity | Morning and evening for 3 days following surgery | No | |
Secondary | Severity of opioid-related adverse effects (i.e., nausea, vomiting, constipation, daytime sedation, lightheadedness or feeling dizzy, and nightmares) | Every evening for 3 days following surgery | No | |
Secondary | Volume and number of times pain medication administered | with each dose for 3 days following surgery | No |
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