Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Colorado
ClinicalTrials.gov Identifier:
NCT00884650
First received: April 16, 2009
Last updated: June 20, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to determine which pain management strategy continuous analgesic pump or orally-should be used in the management of children with cerebral palsy.


Condition Intervention
Cerebral Palsy
Drug: oral analgesic
Drug: intravenous analgesic per pump

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing the Effectiveness of an Anesthetic Continuous-infusion Device to Oral Analgesia in Orthopedic Postoperative Pain Control of Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Children's Hospital Colorado:

Primary Outcome Measures:
  • The primary outcome measures will be the amount of oral analgesic each subject consumed over the 4-day study period and amount of pain analyzed from pain scores for each of the 4 days. [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measure will be parent and patient satisfaction with the post operative pain management. [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: June 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Group 1 will receive oral analgesia only
Drug: oral analgesic
per clinical standard of care
Active Comparator: Group 2
Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
Drug: intravenous analgesic per pump
per clinical standard of care

Detailed Description:

A prospective randomized controlled trial will be performed on up to 150 subjects who will undergo a tendoachilles lengthening, Strayer's procedure, epiphysiodesis of the femur or femoral osteotomy metal work removal.

Subjects will be randomized into two groups: the first group will have an anesthetic pain pump device supplemented with oral analgesia and the second group will only receive oral analgesia. The anesthetic continuous device will be used continuously for 48 hours and with a flow rate of 2ml/hour of 0.25% bupivacaine diluted in accordance to patient weight. Subjects in both groups will receive oral analgesia according to their pain requirements. The amount of oral analgesia used will be documented over 12-hour intervals in a patient diary over a 4 day period. Subjects will have their pain score assessed daily with the use of the Non-Communicating Children's Pain Checklist-Postoperative Version. Their overall satisfaction with post-operative pain management will be assessed at the end of the study with the use of the Parent Total Quality Pain Management questionnaire.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with cerebral palsy between 3 and 17 years old.
  • American Society of Anesthesiologists (ASA) intubation grade I, II or III.
  • Ability of subject or primary caregivers to give informed consent, to understand what the study entails and to be able to complete the patient Pain Diary during the post-operative period. Subjects should be available for daily telephone follow-up until the data is completed and they should be able to return the completed Pain Diary to the Primary Investigator.
  • Willingness and understanding of parent or guardian to have their child randomized to receive either the continuous infusion pain pump device or oral analgesics for their child's pain management.
  • English or Spanish-speaking care parent or guardians who are able to complete the Pain Diary.

Exclusion Criteria:

  • ASA IV or V,
  • Known allergy or sensitivity to bupivacaine,
  • Subjects who will have more than the above mentioned procedure performed during their surgical visit,
  • Subjects with significant kidney or liver disease,
  • Parents/guardians who are assessed by the PI or co-investigators to be unable or unwilling to complete the study's Pain Diary or behavioral tools, and
  • Parents/guardians who are unwilling to allow their child to be randomly assigned to receive either the pain pump with oral analgesics or oral medications alone.
  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: NCT00884650

Locations
United States, Colorado
The Children's Hospital, Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Children's Hospital Colorado
Investigators
Principal Investigator: Frank Chang, MD Children's Hospital Colorado
  More Information

No publications provided

Responsible Party: Frank Chang, MD, The Children's Hospital, Denver
ClinicalTrials.gov Identifier: NCT00884650     History of Changes
Other Study ID Numbers: 040981
Study First Received: April 16, 2009
Last Updated: June 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Colorado:
Pain
Pain management
Cerebral Palsy

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014