Trial | NCT02248493  Report issue

Title

Intravenous Paracetamol for Postoperative Pain
The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    54
The purpose of this study is to define if intravenous paracetamol may improve analgesia and outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively.

Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and adolescents following surgery.
Patients aged 1-18 years undergoing general, plastic or orthopedic surgery with expected moderate to severe pain at least for 24 hours postoperatively, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. At the end of surgical procedure, at skin closure, all patients are given 1,5 mg/kg intravenous ketoprofen and repeated every 8 hours up till 4,5 mg/kg/24 h. Patients in paracetamol group are additionally given the first dose of IV paracetamol 20 mg/kg and repeated 6 and 20 hours postoperatively up till 60 mg/kg/24 h. Patients in the placebo group are given 0.9% sodium chloride 2 ml/kg IV and repeated 6 and 20 hours postoperatively.

After surgery optional rescue analgesia is given on patient request: either tramadol in a dose of 2 mg/kg (up till 4 mg/kg/24h), either patient-controlled analgesia (PCA) with morphine, as indicated according to the standard of care. Patients are evaluated up till 24 hours postoperatively. After that patients are followed up as long as indicated per standard of care.
Study Started
Nov 30
2012
Primary Completion
Mar 31
2017
Study Completion
Mar 31
2017
Last Update
Mar 06
2017

Drug Paracetamol

  • Other names: Acetaminophen

Drug Placebo (for paracetamol)

  • Other names: 0.9% sodium cloride solution, Normal saline solution, Izotonic saline solution

Drug Ketoprofen

  • Other names: Ketonal

Drug Tramadol

Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses. No other opioid is given to these patients.

  • Other names: Tramal

Drug Morphine

administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.

paracetamol and ketoprofen Experimental

paracetamol 20 mg/kg (1% 2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter. ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.

placebo and ketoprofen Placebo Comparator

0.9% sodium chloride (2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter. ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.

Criteria 

Inclusion Criteria:

Patients 1-18 years of age, undergoing general, plastic or orthopedic surgery with expected median to severe pain postoperatively.
physical status of the patient corresponding to American Society of Anesthesiologists (ASA) class 1 or 2
Signed written informed consent by parents/official caregivers.

Exclusion Criteria:

Allergy to paracetamol, ketoprofen, tramadol, morphine or any NSAID
oncologic disease
central nervous system disease
renal dysfunction
hepatic dysfunction
bronchial asthma
ulcer(s) in gastrointestinal system
hemorrhagic diathesis
chronic use of NSAIDs
chronic use of opioids
chronic use of anticoagulants
female patient is known to be pregnant
No Results Posted