Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02112448
Other study ID # K5900208
Secondary ID
Status Completed
Phase N/A
First received March 28, 2014
Last updated September 18, 2016
Start date June 2014
Est. completion date May 2016

Study information

Verified date September 2016
Source Advocate Health Care
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 4 Months
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Intervention

Drug:
continuous infusion
This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.
as needed dosing
This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.
Acetaminophen
Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac
Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study.

Locations

Country Name City State
United States Advocate Children's Hospital Oak Lawn Illinois

Sponsors (1)

Lead Sponsor Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total morphine dosage Total dose of morphine used will be recorded for each patient. Number of 'as needed' bolus doses given will also be recorded. 24 hours No
Secondary Length of stay Length of stay will be recorded for each subject. 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 No
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04992793 - Paediatric Brain Injury Following Cardiac Interventions
Recruiting NCT05213598 - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed NCT04136379 - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed NCT04814888 - 3D Airway Model for Pediatric Patients
Recruiting NCT04920643 - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery N/A
Completed NCT05934578 - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training N/A
Recruiting NCT06041685 - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia N/A
Recruiting NCT05902013 - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation N/A
Not yet recruiting NCT05687292 - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting NCT05524324 - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT N/A
Completed NCT02746029 - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed NCT02537392 - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease N/A
Completed NCT03119090 - Fontan Imaging Biomarkers (FIB) Study
Recruiting NCT02258724 - Swiss National Registry of Grown up Congenital Heart Disease Patients
Completed NCT01966237 - Milrinone Pharmacokinetics and Acute Kidney Injury
Terminated NCT02046135 - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery Phase 2
Recruiting NCT01184404 - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery N/A
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01821287 - Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease N/A