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

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.
 
ClinicalTrials.gov Identifier: NCT02112448
Recruitment Status : Completed
First Posted : April 14, 2014
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Jamie Penk, Advocate Health Care

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.


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Drug: continuous infusion Drug: as needed dosing Drug: Acetaminophen Drug: ketorolac Not Applicable

Detailed Description:

Prior to surgery, eligible patients scheduled for surgery will be sent our standard surgery letter (Attachment A) along with our study informational sheet (Attachment B) describing our study. The study informational sheet will have a telephone number to call to set up a phone appointment to discuss the study with the PI should parents have questions not answered on the sheet. During the pre-operative visit, the study will again be discussed with the parents. Our nurse practitioners will be trained on this study and will obtain written consent at this time. If the parents would like to further discuss the study directly with the PI, this will be arranged prior to surgery.

The PI will be notified by the NPs of all parents who give permission for their child to participate in the study, and he will notify the on service medical team. On the day of surgery, a computerized order for the study will be entered to notify the pharmacy to randomize the subject to the control or treatment group. Randomization will be stratified based on whether the child has DS, as children with DS are known to have a heightened pain response and require large doses of medication to treat pain. Only the pharmacist will know the random assignment, health care providers and subjects/families will be blinded as to treatment arm.

Treatment Group:

Intravenous (IV) drip of 0.03 mg/kg/hour morphine and 0.03 mg/kg/hour midazolam

Control Group:

IV drip of normal saline (NS) at same volume as what the morphine/midazolam drip would be

Both Groups

Subjects in both the control and treatment group will receive the following post-operative pain control orders that are currently in use in the PSHU:

  1. Morphine 0.05 mg/kg/dose IV q 2 hours prn pain score 4 or greater
  2. Midazolam 0.05 mg/kg/dose IV q1 hours prn agitation
  3. Additional prn doses of morphine and midazolam may be given as determined by the treating team (these doses will be recorded in the EMR)
  4. Acetaminophen 30 mg/kg PR x 1 to be given on admission to PSHU post surgery
  5. Acetaminophen 15 mg/kg PR q4 hours to be started 4 hours after first dose
  6. Acetaminophen 15 mg/kg PO q4 hours to be started after subject starts drinking by mouth and PR doses stopped
  7. Ketorolac 0.5 mg/kg/dose IV q 6 hours to start 6-12 hours after surgery when chest tube drainage criteria are met. Will start when chest tube drainage is no longer frankly bloody and if chest tube drainage is less than 3 cc/kg/hour for two hours in a row

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
Study Start Date : June 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Active Comparator: Continuous infusion
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
Continuous morphine/midazolam and 'as needed' doses. Will receive scheduled acetaminophen and ketorolac.
Other Name: acetaminophen and ketorolac are scheduled for this arm of the study

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

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

Active Comparator: As needed dosing
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
morphine and midazolam as needed. Will receive scheduled acetaminophen and ketorolac..
Other Name: acetaminophen and ketorolac are both scheduled for this arm as well

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

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




Primary Outcome Measures :
  1. Total Morphine Dosage [ Time Frame: 24 hours ]
    Total dose of morphine used will be recorded for each patient.


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: 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 ]
    Length of stay will be recorded for each subject.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT02112448


Locations
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United States, Illinois
Advocate Children's Hospital
Oak Lawn, Illinois, United States, 60453
Sponsors and Collaborators
Advocate Health Care
Investigators
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Principal Investigator: Jamie S Penk Advocate Children's Hospital

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Responsible Party: Jamie Penk, physician, Advocate Health Care
ClinicalTrials.gov Identifier: NCT02112448    
Other Study ID Numbers: K5900208
First Posted: April 14, 2014    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jamie Penk, Advocate Health Care:
congenital heart disease, pediatric cardiothoracic surgery
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Acetaminophen
Ketorolac
Ketorolac Tromethamine
Midazolam
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents