Trial · NCT05853263
Morphine IV vs Paracetamol IV in Neonates and Infants After Cardiac Surgery
NCT05853263, Not applicable, Completed, Erasmus Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Morphine IV vs Paracetamol IV in Neonates and Infants After Cardiac Surgery. Trials, record NCT05853263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05853263
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Morphine IV vs Paracetamol IV in Neonates and Infants After Cardiac Surgery
- NCT number
- NCT05853263
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 208 participants, actual
- Lead sponsor
- Erasmus Medical Center
- Conditions
- Analgesia, Congenital Heart Disease, Surgery
- Interventions
- paracetamol, Morphine
- First posted
- 2023-05-10
- Last updated
- 2023-05-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary outcome measure is weight-adjusted cumulative morphine dose in the first 48 hours post-operatively. | 48 hours | dose in micrograms per kilogram |
| Secondary | Incidence of adverse drug reactions | 96 hours | 1. Hemodynamic: hypotension or bradycardia, with the need for intervention by means of medication or a fluid bolus 2. Decreased gastrointestinal motility or intestinal obstruction not directly related to the underlying diagnosis and not previously existing, with the need for intervention 3. Vomiting 4. Number of re-intubations (duration 48 hours) 5. Pediatric delirium as measured by the Sophia Observation Withdrawal Symptoms scale Pediatric Delirium scale (SOS-PD, max score is 16/17, higher score more risk of pediatric delirium) or Cornell Assessment of Pediatric Delirium (CAPD, score \> 9 gives increased risk of delirium) score. |
| Secondary | Non-inferiority analysis of comparing the proportion of patients with one or more Numaric Rating Scale (NRS) scores of at least 4 between groups | 48 hours | Numeric rating scale |
| Secondary | The role of genetic polymorphisms in morphine metabolism | directly before surgery | Genes involved in morphine metabolism: UGT2B7, ABCC3, and OCT1 |
| Secondary | Concomitant use of sedatives | 48 hours | type and dose |
| Secondary | mechanical ventilation duration in hours | immediately after surgery | |
| Secondary | The length of PICU stay | immediately after surgery | Duration of PICU stay in both groups in days |
| Secondary | Role of alarmins in the systemic inflammatory response (only at Wilhelmina Children's hospital) | 48 hours | specific nuclear proteins to be determined (IL-1 alfa, IL-33, HMGB1) |
| Secondary | Analysis of plasma morphine and paracetamo levels in relation to dose after cardia surgery using NONMEM (non-lineair mixed effects modelling). | 48 hours | serum plasma levels of morphine and paracetamol |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38689310 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05853263
GET https://conductscience.org/api/trials/v1/NCT05853263/registered