The aim of the study is to test the hypothesis that intermittent intravenous paracetamol administration in children after cardiac surgery will result in a reduction of at least 30% of the cumulative morphine requirement.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The cumulative morphine consumption during the first 48 hours after cardiac
surgery.
Secondary outcome
Level of pain assessed by validated PD instruments until 48 hours after stop
study medication
Incidence of adverse drug reactions
Incidence of concomitant use of sedative
Hours on ventilation
Incidence of over- and undersedation
Incidence of withdrawal syndrome and pediatric delirium
The length of PICU stay
Use of corticosteroids
Parents postoperative pain measurement two days after discharge
Levels of cortisol and ACTH
Background summary
Adequate post-operative pain relief after cardiac surgery in children is mainly
achieved by opioids. However, worldwide dosing and kind of opioids used vary
greatly, with morphine being the drug of first choice. Morphine has unwanted
hemodynamically and respiratory side effects. Post cardiac surgery patients may
therefore potentially benefit from a non-opioid drug for their pain relief. A
previous study has shown that intravenous paracetamol is effective and opioid
sparing in children after major non cardiac surgery. Intermittent intravenous
administration of paracetamol may therefore result in a significant decrease in
cumulative morphine consumption in the first 48 hours after cardiac surgery.
Also, administration of opioids can influence the concentration of stress
hormones after surgery. In the PACS study, half of the patients do not receive
opioids. we will therefore measure stresshormones (cortisol and ACTH) in all
patients participating in the PACS study as from september 2018 to study the
influence of opioids.
Study objective
The aim of the study is to test the hypothesis that intermittent intravenous
paracetamol administration in children after cardiac surgery will result in a
reduction of at least 30% of the cumulative morphine requirement.
Study design
A prospective multi center randomized double blind study.
Intervention
Patients will be randomized to receive either intermittent intravenous
paracetamol or continuous intravenous morphine up to 48 hours post-operatively.
Morphine will be available as rescue medication for both groups.
Study burden and risks
The risks and burdens associated with this study are negligible. Blood samples
are only taken from an indwelling arterial catheter, which is already in place
for clinical purposes). Sedation and pain scores are observational procedures
already performed for clinical purposes. Possible burden and risk of
participating in the study is the risk of insufficient analgesia after cardiac
surgery with intermittent intravenous paracetamol. Given previous studies on
the postoperative efficacy of paracetamol in children after major non cardiac
surgery, this risk is considered low. Moreover, morphine will be administered
as rescue medication in case of insufficient analgesia in both groups.
Wytemaweg 80 80
Rotterdam 3015 CN
NL
Wytemaweg 80 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Informed consent,;Neonate / infant aged 0-36 months,;Cardiac surgery with the use of CPB.
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
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-001835-20-NL |
| CCMO | NL53085.078.15 |
| OMON | NL-OMON25142 |