Morphine intravenous vs. paracetamol intravenous after cardiac surgery in neonates and infants.

Mrophine IV vs paracetamol IV in neonates and infants after cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25142

Enrollment

204

Registered

2015-09-01

Start date

2015-12-15

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery Congenital Cardiology Pain Morphine Paracetamol Pharmacokinetics Pharmacodynamics

Interventions

1 arm will recieve paracetamol IV intermittend, the other arm will recieve morphine iv continuous. Both studydrugs will be given double blind until 48 hours after cardiac surgery.

Eligibility

Inclusion criteria

Inclusion criteria: Informed consent, Neonate / infant aged 0-36 months, Cardiac surgery with the use of CPB.

Exclusion criteria

Exclusion criteria: No informed consent Known allergy to or intolerance for paracetamol or morphine, Administration of opioids in the 24 hours prior to surgery. Hepatic dysfunction defined as three times the reference value of ALAT/ASAT. Renal insufficiency defined as Pediatric RIFLE category - injury, defined as estimated creatinine clearance reduced by 50% and urine output <0.5 ml/kg/h for 16 hours.

Design outcomes

Primary

Measure	Time frame
Cumulative morphine dose over 48 hours in mcg/kg.	—

Secondary

Measure	Time frame
1. Incidence of adverse drug reactions a. hemodynamically: hypotension or bradycardia, with the need for intervention by means of medication or a fluid bolus. b. Decreased gastro-intestinal motility or intestinal obstruction not directly related to the underlying diagnosis and not previously existing, with the need for intervention. c. Vomiting. d. Number of re-intubations. e. Pediatric delirium as measured by the SOS-PD-scale. 2. Non-inferiority analysis of comparing patients with one or more NRS pain scores ≥4 between groups. 3. DNA analysis will be performed to evaluate the effect of gene polymorphisms on the PK of analgesic medication. 4. Concomitant use of sedatives. 5. The number of hours on ventilation. 6. The length of PICU stay. 7. Role of alarmins in the systemic inflammatory response (only at Wilhelmina Children’s Hospital, UMCUtrecht). 8. To develop a population PKPD-based post-operative pain management algorithm based on the results of this trial.	—

Measure

Time frame

1. Incidence of adverse drug reactions a. hemodynamically: hypotension or bradycardia, with the need for intervention by means of medication or a fluid bolus. b. Decreased gastro-intestinal motility or intestinal obstruction not directly related to the underlying diagnosis and not previously existing, with the need for intervention. c. Vomiting. d. Number of re-intubations. e. Pediatric delirium as measured by the SOS-PD-scale. 2. Non-inferiority analysis of comparing patients with one or more NRS pain scores ≥4 between groups. 3. DNA analysis will be performed to evaluate the effect of gene polymorphisms on the PK of analgesic medication. 4. Concomitant use of sedatives. 5. The number of hours on ventilation. 6. The length of PICU stay. 7. Role of alarmins in the systemic inflammatory response (only at Wilhelmina Children’s Hospital, UMCUtrecht). 8. To develop a population PKPD-based post-operative pain management algorithm based on the results of this trial.

—

Contacts

Public ContactD. Tibboel

Erasmus Medical Center Sophia Children’s Hospital Department of Pediatric Surgical Intensive Care

j.illsley@erasmusmc.nl+31 (0)10 4636567

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)