Home Care Management of Pediatric Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tonsillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

standard care

As needed dosing

Intervention Type OTHER

"As needed" analgesic dosing with a weight-appropriate dose of a nonopioid/opioid combination analgesic, every 4 hours as needed for pain.

Group B

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

standard care

ATC Dosing

Intervention Type OTHER

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

Group C

Group Type EXPERIMENTAL

ATC Dosing

Intervention Type OTHER

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

Structured Pain Management Program

Intervention Type OTHER

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.

Interventions

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Standard Care

standard care

Intervention Type 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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No