Congenital Heart DiseaseNCT02112448
Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
A study testing continuous infusion, as needed dosing and Acetaminophen in people with Congenital Heart Disease, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 4 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- continuous infusion, as needed dosing and Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 months - 4 years (48 months)
- Anticipated cardiothoracic surgery with midline sternotomy incision
- Planned early extubation (e.g. within 3 hours post surgery)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
About this study
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.
Read the 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:
- Morphine 0.05 mg/kg/dose IV q 2 hours prn pain score 4 or greater
- Midazolam 0.05 mg/kg/dose IV q1 hours prn agitation
- Additional prn doses of morphine and midazolam may be given as determined by the treating team (these doses will be recorded in the EMR)
- Acetaminophen 30 mg/kg PR x 1 to be given on admission to PSHU post surgery
- Acetaminophen 15 mg/kg PR q4 hours to be started 4 hours after first dose
- Acetaminophen 15 mg/kg PO q4 hours to be started after subject starts drinking by mouth and PR doses stopped
- 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
- Being tested
- continuous infusion, as needed dosing, Acetaminophen, ketorolac
- Keywords
- congenital heart disease, pediatric cardiothoracic surgery
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous infusionDrug
Also called acetaminophen and ketorolac are scheduled for this arm of the study
Continuous morphine/midazolam and 'as needed' doses. Will receive scheduled acetaminophen and ketorolac.
as needed dosingDrug
Also called acetaminophen and ketorolac are both scheduled for this arm as well
morphine and midazolam as needed. Will receive scheduled acetaminophen and ketorolac..
AcetaminophenDrug
Acetaminophen will be given every 4 hours for a total of 24 hours.
ketorolacDrug
Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: as needed dosing; Drug: Acetaminophen; Drug: ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine Dosage
Total dose of morphine used will be recorded for each patient.
Measured: 24 hours
Secondary outcomes (1)
Length of Stay
Length of stay will be recorded for each subject.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie S Penk, Principal investigator, Advocate Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112448
- Sponsor's protocol ID
- K5900208
- Status last verified
- Sep 2024
- First submitted
- 28 Mar 2014
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT02112448
- Acronym / sponsor ID
- K5900208
- Conditions
- Congenital Heart Disease
- Keywords
- congenital heart disease, pediatric cardiothoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Posted 2 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Morphine 0.05 mg/kg/dose IV q 2 hours prn pain score 4 or greater
- Midazolam 0.05 mg/kg/dose IV q1 hours prn agitation
- Additional prn doses of morphine and midazolam may be given as determined by the treating team (these doses will be recorded in the EMR)
- Acetaminophen 30 mg/kg PR x 1 to be given on admission to PSHU post surgery
- Acetaminophen 15 mg/kg PR q4 hours to be started 4 hours after first dose
- Acetaminophen 15 mg/kg PO q4 hours to be started after subject starts drinking by mouth and PR doses stopped
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Active comparator | Drug: continuous infusion, Drug: Acetaminophen, Drug: ketorolacPatients 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) |
| As needed dosing | Active comparator | Drug: as needed dosing, Drug: Acetaminophen, Drug: ketorolacPatients 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) |
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 3 months - 4 years (48 months)
- Anticipated cardiothoracic surgery with midline sternotomy incision
- Planned early extubation (e.g. within 3 hours post surgery)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous infusionAlso: acetaminophen and ketorolac are scheduled for this arm of the studyContinuous morphine/midazolam and 'as needed' doses. Will receive scheduled acetaminophen and ketorolac. | Drug | Continuous infusion |
| as needed dosingAlso: acetaminophen and ketorolac are both scheduled for this arm as wellmorphine and midazolam as needed. Will receive scheduled acetaminophen and ketorolac.. | Drug | As needed dosing |
| AcetaminophenAcetaminophen will be given every 4 hours for a total of 24 hours. | Drug | As needed dosing, Continuous infusion |
| ketorolacKetorolac 0.5 mg/kg will be given every six hours to all subjects in the study. | Drug | As needed dosing, Continuous infusion |
Primary outcome
Total Morphine Dosage
Time frame: 24 hours
Total dose of morphine used will be recorded for each patient.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie S Penk principal investigator
Advocate Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous infusion, as needed dosing and Acetaminophen in people with Congenital Heart Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Morphine Dosage (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.