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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02248493 |
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Date of registration:
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22/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intravenous Paracetamol for Postoperative Pain
IVPARACET |
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Scientific title:
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The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02248493 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Lithuania
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Contacts
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Name:
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Danguole C Rugyte, MD. PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lithuanian University of Health Sciences |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Recovery of Function
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Child
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Pain, Postoperative
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Intervention(s)
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Drug: Ketoprofen
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Drug: Paracetamol
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Drug: Tramadol
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Drug: Morphine
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Drug: Placebo (for paracetamol)
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Primary Outcome(s)
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change in postoperative intravenous opioid dose
[Time Frame: 24 hours postoperatively]
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Secondary Outcome(s)
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change in pain level (analgesia) assessed by 10 point pain scales
[Time Frame: 24 hours postoperatively]
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change in pain level (analgesia) assessed by 10 point pain scales
[Time Frame: 1 hour postoperatively]
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Secondary ID(s)
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BEC-MF-10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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