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

NCT ID: NCT02112448

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-05-31

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.

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

Conditions

Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

continuous infusion

Intervention Type: DRUG

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

Acetaminophen

Intervention Type: DRUG

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

ketorolac

Intervention Type: DRUG

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

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)

Group Type: ACTIVE_COMPARATOR

as needed dosing

Intervention Type: DRUG

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

Acetaminophen

Intervention Type: DRUG

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

ketorolac

Intervention Type: DRUG

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

Interventions

continuous infusion

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

Intervention Type: DRUG

as needed dosing

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

Intervention Type: DRUG

Acetaminophen

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

Intervention Type: DRUG

ketorolac

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

Intervention Type: DRUG

Other Intervention Names

acetaminophen and ketorolac are scheduled for this arm of the study; acetaminophen and ketorolac are both scheduled for this arm as well

Eligibility 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie S Penk

Role: PRINCIPAL_INVESTIGATOR

Advocate Children's Hospital

Locations

Advocate Children's Hospital

Oak Lawn, Illinois, United States

Countries

United States

Other Identifiers

K5900208

Identifier Type: -

Identifier Source: org_study_id