Morphine vs. intravenous Acetaminophen after surgery in patients under the age of 1 year.

Morphine intravenous vs. Acetaminophen intravenous in neonates and young infants undergoing major, non-cardiac surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26881

Enrollment

Registered

2008-09-05

Start date

2008-03-01

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

Analgesics Acetaminophen Perfalgan Morphine Pediatrics Post operative Post operatieve pijnbestrijding kinderen morfine paracetamol

Interventions

After surgery patients will be randomised for treatment with Morphine or Acetaminophen intravenoously. In case of post operative pain (COMFORT score>=17 and/or VAS>= 4) additional morphine in both g

Eligibility

Inclusion criteria

Inclusion criteria: 1. Informed consent. 2. Neonate / child under the age of one year. 3. Minimal post conceptual age of 36 weeks. 4. Minimal body weight of 1500 grams. 5. Major thoracic (non cardiac) or abdominal surgery, including urological surgery.

Exclusion criteria

Exclusion criteria: 1. Withdrawal of informed consent. 2. Neonate/child with neurological, renal insufficiency, or hepatic dysfunction. 3. Chronic (more than one day) opioid or psychotropic drug (e.g. antiepileptics, benzodiazepines, antidepressants) exposure pre- or postnatal. 4. Opioid exposure <24 hrs before surgery. 5. Receiving ECMO-therapy. 6. Known allergy / intolerance for acetaminophen or morphine.

Design outcomes

Primary

Measure	Time frame
- The absolute amount of morphine in mcg/kg/48 hours is the primary outcome measure.	—

Secondary

Measure	Time frame
Secondary Objective(s): 1. To compare in the first 48 hrs after abdominal or non-cardiac thoracic surgery in infants less than one year of age who receive either acetaminophen IV boluses or morphine IV. a. number of patients needing extra morphine boluses. b. the incidence of opioid related adverse effects; - Vomiting - Hypotension with the need for vaso- active medication or fluid boluses. - Seizures without other demonstrable causes. - Bradycardia other than due to or directly related to the disease or operation. - Decreased gasto-intestinal motility or intestinal obstruction not directly related to the underlying diagnosis or operation and not previously existing, with the need for intervention. c. average pain scores, AUEC of pain score and percentage of abnormal scores (comfort / VAS) d. % of time patient is adequately pain free, based on pain scores. e. body part activity scores using acceleration sensor as surrogate marker of pain and pain thresholds. f. saliva cortisol levels (as surrogate marker of stress). e. renal clearance of acetaminophen and glucuronidation and sulphate formation. g. pharmacogenetic markers (e.g. CYP polymorphisms) PK-PD relationship for acetaminophen IV and morphine in this population three blood samples are taken from an indwelling arterial line.	—

Measure

Time frame

Secondary Objective(s): 1. To compare in the first 48 hrs after abdominal or non-cardiac thoracic surgery in infants less than one year of age who receive either acetaminophen IV boluses or morphine IV. a. number of patients needing extra morphine boluses. b. the incidence of opioid related adverse effects; - Vomiting - Hypotension with the need for vaso- active medication or fluid boluses. - Seizures without other demonstrable causes. - Bradycardia other than due to or directly related to the disease or operation. - Decreased gasto-intestinal motility or intestinal obstruction not directly related to the underlying diagnosis or operation and not previously existing, with the need for intervention. c. average pain scores, AUEC of pain score and percentage of abnormal scores (comfort / VAS) d. % of time patient is adequately pain free, based on pain scores. e. body part activity scores using acceleration sensor as surrogate marker of pain and pain thresholds. f. saliva cortisol levels (as surrogate marker of stress). e. renal clearance of acetaminophen and glucuronidation and sulphate formation. g. pharmacogenetic markers (e.g. CYP polymorphisms) PK-PD relationship for acetaminophen IV and morphine in this population three blood samples are taken from an indwelling arterial line.

—

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)