Home Care Management of Pediatric Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimberly A. Sutters, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00251628
First received: November 8, 2005
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Tonsillectomy
Other: Standard Care
Other: ATC Dosing
Other: Structured Pain Management Program
Other: As needed dosing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home Care Management of Pediatric Pain

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity [ Time Frame: Morning and evening for 3 days following surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Volume and number of times pain medication administered [ Time Frame: with each dose for 3 days following surgery ] [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: June 2000
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Other: Standard Care
standard care
Other: 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 care
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 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 surgery
Other: 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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251628

Locations
United States, California
Children's Hospital Central California
Madera, California, United States, 93638-8762
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kimberly A Sutters, RN, PhD Children's Hospital Central California
  More Information

Publications:

Responsible Party: Kimberly A. Sutters, Kimberly A. Sutters, RN, PhD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00251628     History of Changes
Other Study ID Numbers: CHR #H7097-14918-13, R01NR004826
Study First Received: November 8, 2005
Last Updated: June 7, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Tonsils
Tonsillectomy

ClinicalTrials.gov processed this record on July 23, 2014