Clinical trial NCT02248493: Intravenous Paracetamol for Postoperative Pain
Official title: The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Recovery of Function
Child
Keywords: Pain, Postoperative
Paracetamol
Administration, Intravenous
Anti-Inflammatory Agents, Non-Steroidal
Child
Adolescent
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 54
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: change in postoperative intravenous opioid dose
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: change in pain level (analgesia) assessed by 10 point pain scales
timeFrame: 1 hour postoperatively
measure: change in pain level (analgesia) assessed by 10 point pain scales
timeFrame: 24 hours postoperatively
Other outcomes:
measure: time until the first oral intake after surgery
timeFrame: 24 hours postoperatively
measure: time until the first urination after surgery
timeFrame: 24 hours postoperatively
measure: time until ambulation after surgery
timeFrame: 24 hours postoperatively
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences Kaunas Clinics
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Danguole C Rugyte, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
citation: Wong I, St John-Green C, Walker SM. Opioid-sparing effects of perioperative paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) in children. Paediatr Anaesth. 2013 Jun;23(6):475-95. doi: 10.1111/pan.12163. Epub 2013 Apr 9.
citation: Hiller A, Silvanto M, Savolainen S, Tarkkila P. Propacetamol and diclofenac alone and in combination for analgesia after elective tonsillectomy. Acta Anaesthesiol Scand. 2004 Oct;48(9):1185-9. doi: 10.1111/j.1399-6576.2004.00473.x.
citation: Rugyte D, Kokki H. Intravenous ketoprofen as an adjunct to patient-controlled analgesia morphine in adolescents with thoracic surgery: a placebo controlled double-blinded study. Eur J Pain. 2007 Aug;11(6):694-9. doi: 10.1016/j.ejpain.2006.11.001. Epub 2006 Dec 20.