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Intravenous Paracetamol for Postoperative Pain (IVPARACET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02248493
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Danguole C Rugyte, Lithuanian University of Health Sciences

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
Pain, Postoperative Recovery of Function Child Drug: Paracetamol Drug: Placebo (for paracetamol) Drug: Ketoprofen Drug: Tramadol Drug: Morphine 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children
Study Start Date : November 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketoprofen

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 Name: Acetaminophen

Drug: Ketoprofen
Other Name: Ketonal

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 Name: Tramal

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:
  • 0.9% sodium cloride solution
  • Normal saline solution
  • Izotonic saline solution

Drug: Ketoprofen
Other Name: Ketonal

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 Name: Tramal

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




Primary Outcome Measures :
  1. change in postoperative intravenous opioid dose [ Time Frame: 24 hours postoperatively ]

Secondary Outcome Measures :
  1. change in pain level (analgesia) assessed by 10 point pain scales [ Time Frame: 1 hour postoperatively ]
  2. change in pain level (analgesia) assessed by 10 point pain scales [ Time Frame: 24 hours postoperatively ]

Other Outcome Measures:
  1. time until the first oral intake after surgery [ Time Frame: 24 hours postoperatively ]
  2. time until the first urination after surgery [ Time Frame: 24 hours postoperatively ]
  3. time until ambulation after surgery [ Time Frame: 24 hours postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248493


Locations
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Lithuania
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania, 50009
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
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Principal Investigator: Danguole C Rugyte, MD. PhD Lithuanian University of Health Sciences
Publications:
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Responsible Party: Danguole C Rugyte, MD, PhD, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT02248493    
Other Study ID Numbers: BEC-MF-10
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Keywords provided by Danguole C Rugyte, Lithuanian University of Health Sciences:
Pain, Postoperative
Paracetamol
Administration, Intravenous
Anti-Inflammatory Agents, Non-Steroidal
Child
Adolescent
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ketoprofen
Morphine
Tramadol
Pharmaceutical Solutions
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action