CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 211 enrolled
Drug / intervention
Standard Care +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00251628
NCT00251628Phase 4Completed

Home Care Management of Pediatric Pain

University of California, San Francisco·interventional·Posted Nov 10, 2005·Updated Jun 8, 2012

In Brief

A Phase 4 clinical trial evaluating Standard Care, ATC Dosing, and 2 other interventions for Tonsillectomy. Completed, enrolled 211 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTonsillectomy
CountriesUnited States

Timeline

Phase 4CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2005
Enrollment StartJun 1, 2000
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11.8 yearsPosted 20.6 years ago

Interventions

Standard Careother

standard care

ATC Dosingother

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 Programother

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 dosingother

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