A Phase 4 interventional study of Standard Care and ATC Dosing in Tonsillectomy, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2012-06-08.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
The undertreatment of postoperative pain in children remains a critical problem. Only recently have clinical trials begun to evaluate the efficacy of pharmacologic interventions in the management of postoperative pain beyond the immediate postoperative recovery period and after discharge home following tonsillectomy. Given the fact that approximately 50% of pediatric surgeries are done on an outpatient basis, this study has the potential to improve the home pain management of thousands of children. This study is one of the first to evaluate in a systematic fashion the use of an around-the-clock dosing of a weight appropriate dose of a nonopioid/opioid combination analgesic compared to as needed dosing. Because the study will evaluate the effectiveness of both a behavioral intervention and two different pharmacologic interventions, it will provide important information that should have a direct clinical application in the management of children's pain.
The consent form is written according to the standards outlined by the Committee on Human Research, including: 1) an explanation of the purposes of the research and the expected duration of the subject's participation; 2) a description of the procedures to be followed; 3) a description of any foreseeable risks or benefits to the subject, and any alternative courses of treatment; 4) a statement describing the extent to which confidentiality of records will be maintained; 5) a statement whether compensation will be provided and medical treatment made available if injury occurs; 6) the name and number of the Chair of the Committee on Human Research; 7) a statement that participation is voluntary, and that the subject may discontinue participation at any time; and 8) a statement indicating that the subject has received a copy of the consent document and related materials. A separate form is signed to authorize access to their health care information.
University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
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Exclusion Criteria:
Other: Standard Care · Other: As needed dosing
Other: Standard Care · Other: ATC Dosing
Other: ATC Dosing · Other: Structured Pain Management Program
standard care
ATC dosing of a weight-appropriate dose of a nonopioid/opioid combination analgesic, every 4 hours around-the-clock for the first 3 days following surgery
The structured pain management program consisted of a nurse coaching intervention which included an evaluation of the child's current condition, review of the pain intensity scores, verification that the child was taking the pain medication, re-education regarding the rationale for ATC dosing, review of strategies to facilitate medication administration, and re-education about potential side effects associated with analgesic administration.
"As needed" analgesic dosing with a weight-appropriate dose of a nonopioid/opioid combination analgesic, every 4 hours as needed for pain.
Determine the effectiveness of pain management "over time", compared to standard care with "as needed" dosing.
Time frame: Morning and evening for 3 days following surgery
Pain intensity
Time frame: Morning and evening for 3 days following surgery
Severity of opioid-related adverse effects (i.e., nausea, vomiting, constipation, daytime sedation, lightheadedness or feeling dizzy, and nightmares)
Time frame: Every evening for 3 days following surgery
Volume and number of times pain medication administered
Time frame: with each dose for 3 days following surgery
The record gives a start of Jun 2000, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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