Home Care Management of Pediatric Pain
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|ClinicalTrials.gov Identifier: NCT00251628|
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : June 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tonsillectomy||Other: Standard Care Other: ATC Dosing Other: Structured Pain Management Program Other: As needed dosing||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home Care Management of Pediatric Pain|
|Study Start Date :||June 2000|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
|Active Comparator: Group A||
Other: Standard Care
standard careOther: As needed dosing
"As needed" analgesic dosing with a weight-appropriate dose of a nonopioid/opioid combination analgesic, every 4 hours as needed for pain.
|Active Comparator: Group B||
Other: Standard Care
standard careOther: ATC Dosing
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
|Experimental: Group C||
Other: ATC Dosing
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 surgeryOther: Structured Pain Management Program
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251628
|United States, California|
|Children's Hospital Central California|
|Madera, California, United States, 93638-8762|
|Principal Investigator:||Kimberly A Sutters, RN, PhD||Children's Hospital Central California|