Home Care Management of Pediatric Pain

Phase 4

Completed

• Conditions: Tonsillectomy
• Interventions: Other: Standard Care; Other: As needed dosing; Other: ATC Dosing; Other: Structured Pain Management Program

• Registration Number: NCT00251628
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-10
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	As needed dosing	-
Group A	Standard Care	-
Group B	Standard Care	-
Group B	ATC Dosing	-
Group C	ATC Dosing	-
Group C	Structured Pain Management Program	-

Primary Outcome Measures

Name	Time	Method
Determine the effectiveness of pain management "over time", compared to standard care with "as needed" dosing.	Morning and evening for 3 days following surgery

Secondary Outcome Measures

Name	Time	Method
Pain intensity	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)	Every evening for 3 days following surgery
Volume and number of times pain medication administered	with each dose for 3 days following surgery

Trial Locations

Locations (1)

Children's Hospital Central California; 🇺🇸 Madera, California, United States