Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery

NCT02112448 | Completed Results DMC

• 1 other identifier: K5900208
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that intermittent bolus doses of morphine and midazolam can provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus infusions while using smaller total doses of both medications. The investigators will randomize patients to receive either morphine/midazolam as needed intermittently or morphine/midazolam drips plus intermittent doses to be received as needed. Pain scores will be recorded and total medications given will be recorded.

Conditions

Congenital Heart Disease

Keywords

congenital heart disease, pediatric cardiothoracic surgery

Outcome Measures

Primary Outcomes (1)

• Total Morphine Dosage

  Total dose of morphine used will be recorded for each patient.

  24 hours

Secondary Outcomes (1)

• Length of Stay

  From date of randomization until the date of first documented progression or date of death from any cause or discharge, whichever came first, assessed up to 100 months

Study Arms (2)

Continuous infusion

ACTIVE COMPARATOR

Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)

Drug: continuous infusion; Drug: Acetaminophen; Drug: ketorolac

As needed dosing

ACTIVE COMPARATOR

Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)

Drug: as needed dosing; Drug: Acetaminophen; Drug: ketorolac

Interventions

continuous infusion DRUG

Continuous morphine/midazolam and 'as needed' doses. Will receive scheduled acetaminophen and ketorolac.

Also known as: acetaminophen and ketorolac are scheduled for this arm of the study

Continuous infusion

as needed dosing DRUG

morphine and midazolam as needed. Will receive scheduled acetaminophen and ketorolac..

Also known as: acetaminophen and ketorolac are both scheduled for this arm as well

As needed dosing

Acetaminophen DRUG

Acetaminophen will be given every 4 hours for a total of 24 hours.

As needed dosing; Continuous infusion

ketorolac DRUG

Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study.

As needed dosing; Continuous infusion

Eligibility Criteria

• Age: 3 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 months - 4 years (48 months)
• Anticipated cardiothoracic surgery with midline sternotomy incision
• Planned early extubation (e.g. within 3 hours post surgery)

You may not qualify if:

• Presence of renal insufficiency defined as a creatinine greater than 0.8mg/dL on the standard basic metabolic profile sent after surgery or history of chronic renal failure.
• Significant development delay that the bedside nurse or treating physician judges would make pain scoring difficult (Down syndrome is not excluded)
• History of bleeding disorder or gastrointestinal bleed within the past 2 months.
• Presence of chronic hepatic disease or elevation of AST or ALT greater than 250 U/L before or after surgery.
• More than 3 previous surgeries with a sternotomy incision (this may alter pain perception).
• Children on immunosuppressants

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Acetaminophen; Ketorolac

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jamie Penk
• Organization: Advocate Children's Hospital

jamie.penk@advocatehealth.com

7086845580

Study Officials

• Jamie S Penk

  Advocate Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 14, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 24, 2024
• Results First Posted: June 2, 2017

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)