Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

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.
    

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
    

Intervention name(s): continuous infusion; as needed dosing; Acetaminophen; ketorolac
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Continuous morphine/midazolam and 'as needed' doses. Will receive scheduled acetaminophen and ketorolac.; morphine and midazolam as needed. Will receive scheduled acetaminophen and ketorolac..; Acetaminophen will be given every 4 hours for a total of 24 hours.; Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study.
Other intervention name(s): acetaminophen and ketorolac are scheduled for this arm of the study; acetaminophen and ketorolac are both scheduled for this arm as well
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: congenital heart disease, pediatric cardiothoracic surgery