Intravenous Morphine versus intravenous Paracetamol in children on ECMO.

Morphine iv vs. Paracetamol iv in children on ECMO.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25353

Enrollment

Registered

2010-01-26

Start date

2010-01-25

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Paediatric patients, Morphine iv, Paracetamol iv, ECMO, Critically ill Children, Pharmocokinetics, Pharmacodynamics

Interventions

Patients will be randomised in two groups: 1. Intermittent administration of paracetamol IV boluses + morphine rescue during ECMO treatment (intervention group)

2. Administration of a baseline morphine IV infusion + morphine rescue during ECMO treatment (control group).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Informed consent; 2. Neonate / child under 12y of age; 3. Minimal post conceptual age of 34 weeks; 4. Minimal body weight of 2000 grams; 5. ECMO treatment.

Exclusion criteria

Exclusion criteria: 1. Withdrawal of informed consent; 2. Known allergy / intolerance for acetaminophen or morphine; 3. Prolonged use of muscle blocking agents.

Design outcomes

Primary

Measure	Time frame
Need for total morphine (ìg/kg/ECMO hour) in children included.	—

Secondary

Measure	Time frame
To compare in children on ECMO who receive either paracetamol IV boluses or morphine IV: 1. Number of extra morphine boluses required per patient; 2. The need for additional sedation/ analgetics; 3. Percentage of time that the patient is adequately pain free, based on validated and routinely obtained pain scores; 4. The incidence of opioid related adverse effects: A. Vomiting; B. Seizures without other demonstrable causes; C. Opioid withdrawal symptoms assessed by SOS score and/or the need for prolonged morphine or methadone use; D. Renal and/or CVVH clearance of paracetamol and glucuronidation and sulphate formation; E. Pharmacogenetic markers (e.g. CYP polymorphisms). To determine the PK-PD relationship for paracetamol IV and morphine in this population three blood samples are taken per day from an indwelling arterial line or from the ECMO circuit, with a total amount of 10ml /24 h (<3% of circulating volume without the ECMO circuit). Together with the blood samples, 10 mL urine and 10 mL dialysate samples are taken as well.	—

Measure

Time frame

To compare in children on ECMO who receive either paracetamol IV boluses or morphine IV: 1. Number of extra morphine boluses required per patient; 2. The need for additional sedation/ analgetics; 3. Percentage of time that the patient is adequately pain free, based on validated and routinely obtained pain scores; 4. The incidence of opioid related adverse effects: A. Vomiting; B. Seizures without other demonstrable causes; C. Opioid withdrawal symptoms assessed by SOS score and/or the need for prolonged morphine or methadone use; D. Renal and/or CVVH clearance of paracetamol and glucuronidation and sulphate formation; E. Pharmacogenetic markers (e.g. CYP polymorphisms). To determine the PK-PD relationship for paracetamol IV and morphine in this population three blood samples are taken per day from an indwelling arterial line or from the ECMO circuit, with a total amount of 10ml /24 h (<3% of circulating volume without the ECMO circuit). Together with the blood samples, 10 mL urine and 10 mL dialysate samples are taken as well.

—

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)