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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00884650
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : June 22, 2011
Information provided by:
Children's Hospital Colorado

Brief Summary:
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 or disease Intervention/treatment Phase
Cerebral Palsy Drug: oral analgesic Drug: intravenous analgesic per pump Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The secondary outcome measure will be parent and patient satisfaction with the post operative pain management. [ Time Frame: 4 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884650

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

Responsible Party: Frank Chang, MD, The Children's Hospital, Denver Identifier: NCT00884650     History of Changes
Other Study ID Numbers: 040981
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

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

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