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

NCT00884650 | Completed Results

• 1 other identifier: 04-0981
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Pain; Pain management; Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Parent and Patient Satisfaction With the Post Operative Pain Management.

  4 days

Study Arms (2)

Oral Analgesic Only

ACTIVE COMPARATOR

Group 1 will receive oral analgesic only

Drug: oral analgesic

anesthetic continuous-infusion + oral analgesia

ACTIVE COMPARATOR

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

Drug: intravenous analgesic per pump

Interventions

oral analgesic DRUG

per clinical standard of care

Oral Analgesic Only

intravenous analgesic per pump DRUG

per clinical standard of care

anesthetic continuous-infusion + oral analgesia

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

The Children's Hospital, Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Pain; Agnosia

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Dr. Frank Chang
• Organization: Children's Hospital Colorado

Chang.Frank@tchden.org

720-777-6900

Study Officials

• Frank Chang, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 21, 2009
• Study Start: June 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-08

Locations

US (1)