The aim of this study is to test the hypothesis that intravenous acetaminophen will reduce morphine requirements in postoperative infants significantly (>30%).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Analgesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body weight corrected morphine dose needed in the first 48 hrs postsurgery.
Mean morphine dose needed will be 30% less in the infants receiving
acetaminophen IV as compared to the patients who received only morphine.
Secondary outcome
VAS and COMFORT scale area under the curve.
Occurence of side-effects.
Body part activity scores.
Saliva cortisol levels.
Urine for medication metabolism and renal clearance.
Blood samples for PK-PD data.
Pharmacogenetic markers (e.g. CYP polymorphisms)
Background summary
Patients after non-cardiac thoracic or abdominal major surgery receive Morphine
as pain relief medication whereas this is associated with Morphine related side
effects. In these patients a non-opioid drug could be appropriate for
postoperative pain relief. Intermittent administration of intravenous
Acetaminophen, to young infants up to 48 hrs after major surgery e.g. thoracic
and abdominal, will lead to a clinically significant (>30%) morphine sparing
effect
Study objective
The aim of this study is to test the hypothesis that intravenous acetaminophen
will reduce morphine requirements in postoperative infants significantly
(>30%).
Study design
Single centre prospective, randomized double blind study.
Intervention
Patients will be randomized to receive either intermittent intravenous
acetaminophen or continuous morphine IV infusion up to 48 hrs after surgery,
with additional morphine boluses as escape medication in both groups.
Study burden and risks
Possible burden and risk of study participation is the risk of insufficient
analgesia after surgery with acetaminophen IV. This risk is minimized by the
provision in the protocol for the administration of additional morphine in case
of insufficient analgesia.
Acetaminophen has been widely studied in children over all age ranges and is
deemed safe in the population to be studied when administered in therapeutic
doses.
Benefits of participation can be better observation of the patient in relation
to his/her analgesia and more prompt response with additional morphine if
necessary. Hence, we expect patients in the study to be more pain free than
patients not participating in a pain trial.
Also, if acetaminophen indeed reduces the total morphine dose required, a
reduction in adverse effects of morphine can be expected (less post operative
vomiting, less respiratory depression).
The study can only be carried out in this population as results from adults or
healthy children cannot be extrapolated to this group of patients (critically
ill children), due to differences in age and the underlying disease, which are
mainly life threatening congentital anomalies, resulting in differences in
pharmacokinetics and pharmacodynamics of both drugs.
Dr. Molenwaterplein 60
3015 GJ Rotterdam
NL
Dr. Molenwaterplein 60
3015 GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Potential participants will be term infants (>35 wks of gestational age) less than one year of age, who are admitted to the ICU after major thoracic (non-cardiac) or abdominal surgery.
Exclusion criteria
- Withdrawal of informed consent
- Neonates with neurological, renal insufficiency, or hepatic dysfunction.
- Chronic (more than one day) opioid or psychotropic drug (e.g. antiepileptics, benzodiazepines, antidepressants) exposure pre- or postnatally
- Opioid exposure <24 hrs before surgery
- Receiving ECMO-therapy.
- Known allergy / intolerance for acetaminophen or morphine
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-005619-24-NL |
| CCMO | NL20093.078.07 |