Intravenous Paracetamol for Postoperative Pain

Pain, Postoperative Clinical Trial

— IVPARACET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248493
• Other study ID #: BEC-MF-10
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2014
• Last updated: March 3, 2017
• Start date: November 2012
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Pain, Postoperative
• Recovery of Function

Intervention

Drug:
• Paracetamol

• Placebo (for paracetamol)

• Ketoprofen

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

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences Kaunas Clinics	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time until the first oral intake after surgery		24 hours postoperatively
Other	time until the first urination after surgery		24 hours postoperatively
Other	time until ambulation after surgery		24 hours postoperatively
Primary	change in postoperative intravenous opioid dose		24 hours postoperatively
Secondary	change in pain level (analgesia) assessed by 10 point pain scales		1 hour postoperatively
Secondary	change in pain level (analgesia) assessed by 10 point pain scales		24 hours postoperatively