Intravenous Paracetamol for Postoperative Pain

NCT ID: NCT02248493

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2017-03-31

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.

Conditions

Pain, Postoperative; Recovery of Function; Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: DRUG

Ketoprofen

Intervention Type: DRUG

Tramadol

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo (for paracetamol)

Intervention Type: DRUG

Ketoprofen

Intervention Type: DRUG

Tramadol

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

Paracetamol

Intervention Type: DRUG

Placebo (for paracetamol)

Intervention Type: DRUG

Ketoprofen

Intervention Type: 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.

Intervention Type: DRUG

Morphine

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

Intervention Type: DRUG

Other Intervention Names

Acetaminophen; 0.9% sodium cloride solution; Normal saline solution; Izotonic saline solution; Ketonal; Tramal

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Danguole C Rugyte

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danguole C Rugyte, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences

Locations

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Countries

Lithuania

References

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.

Reference Type: BACKGROUND

PMID: 20142348 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23570544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15352967 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17185016 (View on PubMed)

Other Identifiers

BEC-MF-10

Identifier Type: -

Identifier Source: org_study_id