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

NCT02112448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-10-24

Study results available
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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.

Conditions

  • Congenital Heart Disease

Interventions

DRUG

continuous infusion

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

DRUG

as needed dosing

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

DRUG

Acetaminophen

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

DRUG

ketorolac

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Jamie S Penk · Advocate Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112448 on ClinicalTrials.gov