IVPARACET: Intravenous Paracetamol for Postoperative Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: paracetamol and ketoprofen 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. |
Drug: Paracetamol
Other Names:
Drug: Ketoprofen
Other Names:
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:
Drug: Morphine
administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.
|
| Placebo Comparator: placebo and ketoprofen 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. |
Drug: Placebo (for paracetamol)
Other Names:
Drug: Ketoprofen
Other Names:
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:
Drug: Morphine
administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.
|
Outcome Measures
Primary Outcome Measures
- change in postoperative intravenous opioid dose [24 hours postoperatively]
Secondary Outcome Measures
- change in pain level (analgesia) assessed by 10 point pain scales [1 hour postoperatively]
- change in pain level (analgesia) assessed by 10 point pain scales [24 hours postoperatively]
Other Outcome Measures
- time until the first oral intake after surgery [24 hours postoperatively]
- time until the first urination after surgery [24 hours postoperatively]
- time until ambulation after surgery [24 hours postoperatively]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | Lithuania | 50009 |
Sponsors and Collaborators
- Lithuanian University of Health Sciences
Investigators
- Principal Investigator: Danguole C Rugyte, MD. PhD, Lithuanian University of Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- 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. Epub 2006 Dec 20.
- 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. Review.
- BEC-MF-10