Home Care Management of Pediatric Pain

NCT00251628 | Completed Phase 4

• 2 other identifiers: CHR #H7097-14918-13R01NR004826
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy

Keywords

Tonsils; Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Group A

ACTIVE COMPARATOR

Other: Standard Care; Other: As needed dosing

Group B

ACTIVE COMPARATOR

Other: Standard Care; Other: ATC Dosing

Group C

EXPERIMENTAL

Other: ATC Dosing; Other: Structured Pain Management Program

Interventions

Standard Care OTHER

standard care

Group A; Group B

ATC Dosing 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 B; Group C

Structured Pain Management Program 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.

Group C

As needed dosing OTHER

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

Group A

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Related Publications (6)

• Sutters KA, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B. A randomized clinical trial of the effectiveness of a scheduled oral analgesic dosing regimen for the management of postoperative pain in children following tonsillectomy. Pain. 2004 Jul;110(1-2):49-55. doi: 10.1016/j.pain.2004.03.008.

  PMID: 15275751 BACKGROUND

• Sutters KA, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B. Time-contingent dosing of an opioid analgesic after tonsillectomy does not increase moderate-to-severe side effects in children. Pain Manag Nurs. 2005 Jun;6(2):49-57. doi: 10.1016/j.pmn.2005.01.001.

  PMID: 15970918 BACKGROUND

• Sutters KA, Savedra MC, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Lanier B. Children's expectations of pain, perceptions of analgesic efficacy, and experiences with nonpharmacologic pain management strategies at home following tonsillectomy. J Spec Pediatr Nurs. 2007 Jul;12(3):139-48. doi: 10.1111/j.1744-6155.2007.00107.x.

  PMID: 17594294 BACKGROUND

• Sutters KA, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B, Mahoney K, Miaskowski C. A descriptive feasibility study to evaluate scheduled oral analgesic dosing at home for the management of postoperative pain in preschool children following tonsillectomy. Pain Med. 2012 Mar;13(3):472-83. doi: 10.1111/j.1526-4637.2011.01324.x. Epub 2012 Feb 7.

  PMID: 22313591 BACKGROUND

• Sutters KA, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B, Mahoney K. A randomized clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after tonsillectomy. Clin J Pain. 2010 Feb;26(2):95-103. doi: 10.1097/AJP.0b013e3181b85f98.

  PMID: 20090434 RESULT

• Sutters KA, Savedra MC, Miaskowski C. The pediatric PRO-SELF(c): pain control program: an effective educational program for parents caring for children at home following tonsillectomy. J Spec Pediatr Nurs. 2011 Oct;16(4):280-94. doi: 10.1111/j.1744-6155.2011.00299.x. Epub 2011 Aug 12.

  PMID: 21951354 RESULT

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kimberly A Sutters, RN, PhD

  Children's Hospital Central California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kimberly A. Sutters, RN, PhD

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 10, 2005
• Study Start: June 1, 2000
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

US (1)