Home Care Management of Pediatric Pain
Condition: Tonsillectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Standard Care; ATC Dosing; Structured Pain Management Program; As needed dosing
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tonsils; Tonsillectomy