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Intravenous Paracetamol for Postoperative Pain

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02248493
Acronym
IVPARACET
Enrollment
54
Registered
2014-09-25
Start date
2012-11-30
Completion date
2017-03-31
Last updated
2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Pain, Postoperative, Recovery of Function

Keywords

Pain, Postoperative, Paracetamol, Administration, Intravenous, Anti-Inflammatory Agents, Non-Steroidal, Child, Adolescent

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.

Interventions

DRUGMorphine

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

DRUGParacetamol
DRUGPlacebo (for paracetamol)
DRUGKetoprofen
DRUGTramadol

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.

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
change in postoperative intravenous opioid dose24 hours postoperatively

Secondary

MeasureTime frame
change in pain level (analgesia) assessed by 10 point pain scales1 hour postoperatively

Other

MeasureTime frame
time until the first oral intake after surgery24 hours postoperatively
time until the first urination after surgery24 hours postoperatively
time until ambulation after surgery24 hours postoperatively

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026