Pancreatitis, AcutePhase 4NCT07024199
Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children
A Phase 4 study testing The initial pain assessment, Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol) and The effectiveness of the treatment in people with Pancreatitis, Acute and Pain, Acute, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of the study is to assess the effectiveness and tolerance of pain treatment in AP in children using intravenous paracetamol in combination with ibuprofen or paracetamol in combination with metamizole. The study is prospective, interventional, and randomized. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pancreatitis, Acute, Pain, Acute, Pancreatic Disease
- What is being tested?
- The initial pain assessment, Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol) and The effectiveness of the treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2025to 1 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of AP according to the INSPPIRE mentioned above criteria,
- age from 3 to 18 years of age,
- abdominal pain on admission assessed on the Numerical Rating Scale (NRS) or FLACC >= 4 points,
- no analgesic treatment before enrolment in the study OR the last dose of analgesic drug (paracetamol, ibuprofen, metamizole) taken ≥ 6 hours before enrolment for examination,
- consent of legal guardians and the child (in the case of patients ≥16 years of age) to participate in the study.
Who cannot join
- who took the last dose of painkiller (paracetamol, ibuprofen, metamizole) < 6 hours before entering the study,
- allergic to acetylsalicylic acid, other NSAIDs, paracetamol, metamizole,
- with inflammatory bowel disease,
- with gastrointestinal bleeding and other active bleeding,
- with gastric and/or duodenal ulcer disease,
- chronically taking paracetamol, NSAIDs, metamizole,
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- with liver failure,
- with heart failure according to the NYHA II-IV scale,
- with acute and chronic renal failure,
- with cancer,
- whose legal guardians did not consent to participate in the study,
- who did not consent to participate in the study (applies to patients > 16 years of age).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Paediatric Gastroenterology and Nutrition
Warsaw, 02-091
Jan Bukowski, MD, PhD, bukowski.janek@gmail.com
Aleksandra Banaszkiewicz, MD PhD, Prof.
About this study
Official title: Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children: a Randomized Trial
The aim of the study is to assess the effectiveness and tolerance of pain treatment in AP in children using intravenous paracetamol in combination with ibuprofen or paracetamol in combination with metamizole. The study is prospective, interventional, and randomized.
Read the detailed description
Patients with AP diagnosed based on the INSPIRE criteria who meet the inclusion as mentioned above criteria for the study will be randomized (based on a computer-generated randomization list, in blocks of four people) to treatment with one of two regimens:
Group A will receive a dose of paracetamol intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and ibuprofen 10 mg/kg body weight (maximum 400 mg/dose).
Group B will receive a dose of paracetamol intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and metamizole 15 mg/kg body weight (maximum 100 mg/dose).
The initial pain assessment will be carried out according to pain assessment scales in children adapted to the patient's age and cognitive abilities (NRS, Wong-Baker Faces Scale/FLACC- attached). The effectiveness of the treatment will be assessed 60 minutes after the start of the intervention.
Before starting the intervention, all patients during obtaining peripheral intravenous access will undergo a panel of laboratory tests including: alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase activity, total, conjugated and unconjugated bilirubin level, peripheral blood morphology, C-reactive protein, glucose, creatinine, calcium, albumin and urea nitrogen level. Oral and/or intravenous fluid supply in the range of 1.5 to 2 times the daily requirement will be provided, as well as early low-fat enteral nutrition.
After the intervention is completed, the decision on further analgesic treatment will remain at the discretion of the attending physician.
In addition, during the examination, data about the patient will be collected, such as: age, gender, body weight, height, history of chronic diseases and congenital defects, medications taken, reported allergies and family history, with particular emphasis on pancreatic diseases, as well as the results of laboratory tests and imaging, as well as data on possible side effects of the treatment. The patient will be observed for 48 hours from the start of the intervention.
- Conditions
- Pancreatitis, Acute, Pain, Acute, Pancreatic Disease, Pancreatic Diseases, Gastroenterology, Pancreatitis
- Being tested
- The initial pain assessment, Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol), The effectiveness of the treatment
- Keywords
- acute pancreatitis, acute pain, painkillers, pancreatitis
- Medical subject headings
- Pancreatitis, Acute Pain, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The initial pain assessmentOther
The initial pain assessment will be carried out according to pain assessment scales in children adapted to the patient's age and cognitive abilities (NRS, FLACC).
Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol)Drug
Group A will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Ibuprofen B.Braun/Ibuprofen Kabi intravenously 10 mg/kg body weight (maximum 400 mg/dose).
Group B will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Metamizol-SF/Metamizole Kabi/Pyralgin intravenously 15 mg/kg body weight (maximum 100 mg/dose).
The effectiveness of the treatmentOther
The effectiveness of the treatment will be assessed 60 minutes after the start of the intervention according to pain assessment scales in children adapted to the patient's age and cognitive abilities (NRS, FLACC).
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol + Iburprofen | Experimental | Group A will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Ibuprofen B.Braun/Ibuprofen Kabi intravenously 10 mg/kg body weight (maximum 400 mg/dose). Receives: Other: The initial pain assessment; Drug: Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol); Other: The effectiveness of the treatment |
| Paracetamol + Metamizol | Experimental | Group B will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Metamizol-SF/Metamizole Kabi/Pyralgin intravenously 15 mg/kg body weight (maximum 100 mg/dose). Receives: Other: The initial pain assessment; Drug: Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol); Other: The effectiveness of the treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain intensity assessed at the 60th minute of the examination using ONE of the SCALES.
The number of patients who observed a reduction in pain intensity of <4 points on the NRS scale (for children from 7 years of age) or FLACC scale (for children from 3 to 7 years of age) in both study groups, assessed at the 60th minute of the study.
NRS is used to assess pain severity at a given moment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
The FLACC scale [Face, Legs, Activity, Cry, Consolability] is used to assess pain between the ages of 2 months and 7 years or in individuals who are unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain. The scale has 5 criteria, which are each assigned a score of 0, 1 or 2.
Measured: at the 60th minute after introduction of the intervention
Secondary outcomes (3)
Length of hospitalization.
Length of hospitalization in both study groups.
Measured: at the time of discharge (up to 14 days)
Consumption of opioid drugs.
Consumption of opioid drugs within 48 hours from the start of the study calculated per morphine equivalent/kg body weight.
Measured: at the 48th hour after introduction of the intervention
Reduction in pain intensity assessed at the 6th, 24th and 48th hour.
The number of patients who observed a reduction in pain intensity by at least 2 points on the NRS scale (for children aged 7 years and over) or FLACC scale (for children aged 3 to 7 years) in both study groups, assessed at 6, 24, and 48 hours of the study.
NRS is used to assess pain severity at a given moment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
The FLACC scale [Face, Legs, Activity, Cry, Consolability] is used to assess pain between the ages of 2 months and 7 years or in individuals who are unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain. The scale has 5 criteria, which are each assigned a score of 0, 1 or 2.
Measured: at 6th, 24th and 48th hour after introduction of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startSep 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Banaszkiewicz, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024199
- Sponsor's protocol ID
- APPain
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children: a Randomized Trial
- ClinicalTrials.gov ID
- NCT07024199
- Acronym / sponsor ID
- APPain
- Conditions
- Pancreatitis, Acute, Pain, Acute, Pancreatic Disease, Pancreatic Diseases, Gastroenterology, Pancreatitis
- Keywords
- acute pancreatitis, acute pain, painkillers, pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- 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 aim of the study is to assess the effectiveness and tolerance of pain treatment in AP in children using intravenous paracetamol in combination with ibuprofen or paracetamol in combination with metamizole. The study is prospective, interventional, and randomized.
Detailed description
Patients with AP diagnosed based on the INSPIRE criteria who meet the inclusion as mentioned above criteria for the study will be randomized (based on a computer-generated randomization list, in blocks of four people) to treatment with one of two regimens:
Group A will receive a dose of paracetamol intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and ibuprofen 10 mg/kg body weight (maximum 400 mg/dose).
Group B will receive a dose of paracetamol intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and metamizole 15 mg/kg body weight (maximum 100 mg/dose).
The initial pain assessment will be carried out according to pain assessment scales in children adapted to the patient's age and cognitive abilities (NRS, Wong-Baker Faces Scale/FLACC- attached). The effectiveness of the treatment will be assessed 60 minutes after the start of the intervention.
Before starting the intervention, all patients during obtaining peripheral intravenous access will undergo a panel of laboratory tests including: alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase activity, total, conjugated and unconjugated bilirubin level, peripheral blood morphology, C-reactive protein, glucose, creatinine, calcium, albumin and urea nitrogen level. Oral and/or intravenous fluid supply in the range of 1.5 to 2 times the daily requirement will be provided, as well as early low-fat enteral nutrition.
After the intervention is completed, the decision on further analgesic treatment will remain at the discretion of the attending physician.
In addition, during the examination, data about the patient will be collected, such as: age, gender, body weight, height, history of chronic diseases and congenital defects, medications taken, reported allergies and family history, with particular emphasis on pancreatic diseases, as well as the results of laboratory tests and imaging, as well as data on possible side effects of the treatment. The patient will be observed for 48 hours from the start of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol + Iburprofen | Experimental | Other: The initial pain assessment, Drug: Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol), Other: The effectiveness of the treatmentGroup A will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Ibuprofen B.Braun/Ibuprofen Kabi intravenously 10 mg/kg body weight (maximum 400 mg/dose). |
| Paracetamol + Metamizol | Experimental | Other: The initial pain assessment, Drug: Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol), Other: The effectiveness of the treatmentGroup B will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Metamizol-SF/Metamizole Kabi/Pyralgin intravenously 15 mg/kg body weight (maximum 100 mg/dose). |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- diagnosis of AP according to the INSPPIRE mentioned above criteria,
- age from 3 to 18 years of age,
- abdominal pain on admission assessed on the Numerical Rating Scale (NRS) or FLACC >= 4 points,
- no analgesic treatment before enrolment in the study OR the last dose of analgesic drug (paracetamol, ibuprofen, metamizole) taken ≥ 6 hours before enrolment for examination,
- consent of legal guardians and the child (in the case of patients ≥16 years of age) to participate in the study.
Key exclusion criteria (12 listed)
- who took the last dose of painkiller (paracetamol, ibuprofen, metamizole) < 6 hours before entering the study,
- allergic to acetylsalicylic acid, other NSAIDs, paracetamol, metamizole,
- with inflammatory bowel disease,
- with gastrointestinal bleeding and other active bleeding,
- with gastric and/or duodenal ulcer disease,
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 |
|---|---|---|
| The initial pain assessmentThe initial pain assessment will be carried out according to pain assessment scales in children adapted to the patient's age and cognitive abilities (NRS, FLACC). | Other | Paracetamol + Iburprofen, Paracetamol + Metamizol |
| Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol)Group A will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Ibuprofen B.Braun/Ibuprofen Kabi intravenously 10 mg/kg body weight (maximum 400 mg/dose). Group B will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Metamizol-SF/Metamizole Kabi/Pyralgin intravenously 15 mg/kg body weight (maximum 100 mg/dose). | Drug | Paracetamol + Iburprofen, Paracetamol + Metamizol |
| The effectiveness of the treatmentThe effectiveness of the treatment will be assessed 60 minutes after the start of the intervention according to pain assessment scales in children adapted to the patient's age and cognitive abilities (NRS, FLACC). | Other | Paracetamol + Iburprofen, Paracetamol + Metamizol |
Primary outcome
Reduction in pain intensity assessed at the 60th minute of the examination using ONE of the SCALES.
Time frame: at the 60th minute after introduction of the intervention
The number of patients who observed a reduction in pain intensity of <4 points on the NRS scale (for children from 7 years of age) or FLACC scale (for children from 3 to 7 years of age) in both study groups, assessed at the 60th minute of the study. NRS is used to assess pain severity at a given moment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable." The FLACC scale [Face, Legs, Activity, Cry, Consolability] is used to assess pain between the ages of 2 months and 7 years or in individuals who are unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain. The scale has 5 criteria, which are each assigned a score of 0, 1 or 2.
3 secondary outcomes
Length of hospitalization.
Time frame: at the time of discharge (up to 14 days)
Consumption of opioid drugs.
Time frame: at the 48th hour after introduction of the intervention
Reduction in pain intensity assessed at the 6th, 24th and 48th hour.
Time frame: at 6th, 24th and 48th hour after introduction of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 The initial pain assessment, Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol) and The effectiveness of the treatment in people with Pancreatitis, Acute and Pain, Acute, run by Medical University of Warsaw at 1 site in Poland.
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 5 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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 Poland. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Banaszkiewicz, M.D., PhD (+48 22 317 9451, aleksandra.banaszkiewicz@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain intensity assessed at the 60th minute of the examination using ONE of the SCALES. (time frame: at the 60th minute after introduction of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.