Pain, PostoperativePhase 4IVPARACETNCT02248493
Intravenous Paracetamol for Postoperative Pain
A Phase 4 study testing Paracetamol, Ketoprofen and Tramadol in people with Pain, Postoperative and Recovery of Function, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pain, Postoperative, Recovery of Function, Child
- What is being tested?
- Paracetamol, Ketoprofen and Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteLithuania
- Study dates
- Nov 2012to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Allergy to paracetamol, ketoprofen, tramadol, morphine or any NSAID
- oncologic disease
- central nervous system disease
- renal dysfunction
- hepatic dysfunction
- bronchial asthma
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50009
About this study
Official title: The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children
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.
Read the 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
- Being tested
- Paracetamol, Placebo (for paracetamol), Ketoprofen, Tramadol, Morphine
- Keywords
- Pain, Postoperative, Paracetamol, Administration, Intravenous, Anti-Inflammatory Agents, Non-Steroidal, Child, Adolescent
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen
Placebo (for paracetamol)Drug
Also called 0.9% sodium cloride solution, Normal saline solution, Izotonic saline solution
KetoprofenDrug
Also called Ketonal
TramadolDrug
Also called Tramal
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.
MorphineDrug
administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.
| Study group | Role | What they receive |
|---|---|---|
| paracetamol and ketoprofen | Experimental | 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. Receives: Drug: Paracetamol; Drug: Ketoprofen; Drug: Tramadol; Drug: Morphine |
| placebo and ketoprofen | Placebo comparator | 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. Receives: Drug: Placebo (for paracetamol); Drug: Ketoprofen; Drug: Tramadol; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in postoperative intravenous opioid dose
Measured: 24 hours postoperatively
Secondary outcomes (2)
change in pain level (analgesia) assessed by 10 point pain scales
Measured: 1 hour postoperatively
change in pain level (analgesia) assessed by 10 point pain scales
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startNov 2012
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danguole C Rugyte, Lithuanian University of Health Sciences
- Investigators
- Danguole C Rugyte, MD. PhD, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248493
- Sponsor's protocol ID
- BEC-MF-10
- Acronym
- IVPARACET
- Status last verified
- Mar 2017
- First submitted
- 22 Sep 2014
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20142348Wong 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.
PubMed 23570544Hiller 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.
PubMed 15352967Rugyte 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.
PubMed 17185016
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children
- ClinicalTrials.gov ID
- NCT02248493
- Acronym / sponsor ID
- IVPARACET / BEC-MF-10
- Conditions
- Pain, Postoperative, Recovery of Function, Child
- Keywords
- Pain, Postoperative, Paracetamol, Administration, Intravenous, Anti-Inflammatory Agents, Non-Steroidal, Child, Adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracetamol and ketoprofen | Experimental | Drug: Paracetamol, Drug: Ketoprofen, Drug: Tramadol, Drug: Morphineparacetamol 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. |
| placebo and ketoprofen | Placebo comparator | Drug: Placebo (for paracetamol), Drug: Ketoprofen, Drug: Tramadol, Drug: Morphine0.9% 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Allergy to paracetamol, ketoprofen, tramadol, morphine or any NSAID
- oncologic disease
- central nervous system disease
- renal dysfunction
- hepatic dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: Acetaminophen | Drug | paracetamol and ketoprofen |
| Placebo (for paracetamol)Also: 0.9% sodium cloride solution, Normal saline solution, Izotonic saline solution | Drug | placebo and ketoprofen |
| KetoprofenAlso: Ketonal | Drug | paracetamol and ketoprofen, placebo and ketoprofen |
| TramadolAlso: TramalAdministered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses. No other opioid is given to these patients. | Drug | paracetamol and ketoprofen, placebo and ketoprofen |
| Morphineadministered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients. | Drug | paracetamol and ketoprofen, placebo and ketoprofen |
Primary outcome
change in postoperative intravenous opioid dose
Time frame: 24 hours postoperatively
2 secondary outcomes
change in pain level (analgesia) assessed by 10 point pain scales
Time frame: 1 hour postoperatively
change in pain level (analgesia) assessed by 10 point pain scales
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Background: PubMed 20142348Ong 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.
- Background: PubMed 23570544Wong 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.
- Background: PubMed 15352967Hiller 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.
- Background: PubMed 17185016Rugyte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danguole C Rugyte, MD. PhD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol, Ketoprofen and Tramadol in people with Pain, Postoperative and Recovery of Function, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in postoperative intravenous opioid dose (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248493, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.