N/A
Completed N=78
Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
Source: ClinicalTrials.gov NCT02112448 ↗Enrolled (actual)
78
Serious AEs
1.3%
Results posted
Jun 2017
Primary outcomePrimary: Total Morphine Dosage — 0.9; 0.23 mg/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Morphine Dosage |
0.9; 0.23 | — |
| SECONDARY Length of Stay |
4.9; 8.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT02112448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.