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

NCT ID: NCT00884650

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2008-04-30

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.

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Analgesic Only

Group 1 will receive oral analgesic only

Group Type: ACTIVE_COMPARATOR

oral analgesic

Intervention Type: DRUG

per clinical standard of care

anesthetic continuous-infusion + oral analgesia

Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia

Group Type: ACTIVE_COMPARATOR

intravenous analgesic per pump

Intervention Type: DRUG

per clinical standard of care

Interventions

oral analgesic

per clinical standard of care

Intervention Type: DRUG

intravenous analgesic per pump

per clinical standard of care

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

The Children's Hospital, Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

04-0981

Identifier Type: -

Identifier Source: org_study_id