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

Comparing the Effectiveness of an Anesthetic Continuous-infusion Device to Oral Analgesia in Orthopedic Postoperative Pain Control of Children With Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Drug: oral analgesic; Drug: intravenous analgesic per pump

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
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • The Children's Hospital, Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Analgesic Only; Group 1 will receive oral analgesic only	Drug: oral analgesic; per clinical standard of care
Active Comparator: anesthetic continuous-infusion + oral analgesia; Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia	Drug: intravenous analgesic per pump; per clinical standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.	Results of Mean and total Medication administered between the 2 groups over a 4 day period (Mean Medication Administered in mg/kg; SD)	4 days
The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days.	Pain scores were assessed using a Visual Analog Scale. Possible scores range from 0 (no pain) to 10 (Worst possible pain).	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent and Patient Satisfaction With the Post Operative Pain Management.	Parent responses to questions about pain management traditional paper-based Q method (TPQM) questionnaire.	4 days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Frank Chang, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: April 16, 2009
• First Submitted That Met QC Criteria: April 20, 2009
• First Posted (Estimate): April 21, 2009

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Pain; Pain management
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 04-0981