Pain, PostoperativePhase 4PANSAIDNCT02571361
PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial
A Phase 4 study testing Paracetamol (1g x 4), Ibuprofen (400 mg x 4) and Paracetamol (0,5 g x 4) in people with Pain, Postoperative, run by Daniel Hägi-Pedersen at 6 sites in Denmark.
Trial summary
Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial Trial acronym: PANSAID Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Paracetamol (1g x 4), Ibuprofen (400 mg x 4) and Paracetamol (0,5 g x 4)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 556 participants
- Where
- 6 sitesDenmark
- Study dates
- Nov 2015to Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for unilateral, primary Total Hip Arthroplasty (THA)
- Age > 18
- ASA 1-3.
- BMI > 18 and < 40
- Women in the fertile age must have negative urine HCG pregnancy test
- Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.
Who cannot join
- Patients who cannot cooperate with the trial.
- Concomitant participation in another trial
- Patients who cannot understand or speak Danish.
- Daily use of strong opioids (tramadol and codein are accepted)
- Patients with allergy to the medicines used in the trial.
- Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)
- Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Gildhøj Privathospital
Copenhagen, Brøndby, 2605
Holbæk Hospital
Holbæk, 4300
Køge Hospital
Køge, 4600
Næstved Hospital
Næstved, 4700
Nykøbing Falster Hospital
Nykøbing Falster, 4800
Odense University Hospital (OUH)
Odense, 5000
About this study
Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial
Trial acronym: PANSAID
Read more
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.
Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.
Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.
Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.
Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.
Read the detailed description
Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial
Trial acronym: PANSAID
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.
Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.
Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.
Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.
Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.
Sub-studies: We preplan the following sub-studies. :
- A subgroup analysis of benefit outcomes (pain and opioid consumption) with respect to the following sub-groups: sex, age (below vs above 65 years old), ASA-score (I+II vs III), Use of analgesic medication before surgery (none vs any) and anaesthetic technique (general anaesthesia vs. spinal anaesthesia). Please find a detailed protocol at www.pansaid.dk
- A subgroup analysis of harm (serious adverse events and adverse events) with respect to the following groups sex, age (below vs above 65 years old), use of NSAIDs before surgery, and ASA-score (I+II vs III). Please find a detailed protocol at www.pansaid.dk
- Longer follow-up than the specified 90 days (1 year)
- An analysis of the association between VAS-scores and opioid consumption
- Time-to-event analyses regarding use of PCA-morphine
- An analysis of the association between preoperative analgesic use and pain/morphine consumption
- An analysis of the individual patients: how many will achieve "no worse than mild pain" (NRS<3). Please find a detailed protocol at www.pansaid.dk
More sub-studies may be performed post-hoc and they will be clearly identified as such.
Oversight of amendments and approvals Protocol version 2: Approved 12 August 2015: First approved version of the trial protocol
Protocol version 3: Approved 21 January 2016: Clarification of what happens in case of an SAE and definition of major protocol violations
Protocol version 4: Approved 15 June 2016: Clarification of the primary outcome, clarification that steroids are not permitted in the intervention period, and addition of an exploratory outcome (dizziness)
Protocol version 5: Approved 21 December 2016: Clarification of the exclusion criteria of contraindication to paracetamol and addition of stub-studies
- Conditions
- Pain, Postoperative
- Being tested
- Paracetamol (1g x 4), Ibuprofen (400 mg x 4), Paracetamol (0,5 g x 4), Ibuprofen (200 mg x 4), Placebo (x4)
- Keywords
- Acetaminophen, Ibuprofen, Arthroplasty, Replacement, Hip
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol (1g x 4)Drug
Also called Acetaminophen
Dose of 1 g given in 6 hour intervals the first 24 hours postoperatively
Ibuprofen (400 mg x 4)Drug
Dose of 400 mg given in 6 hour intervals the first 24 hours postoperatively
Paracetamol (0,5 g x 4)Drug
Also called Acetaminophen
Dose of 0,5 g given in 6 hour intervals the first 24 hours postoperatively
Ibuprofen (200 mg x 4)Drug
Dose of 200 mg given in 6 hour intervals the first 24 hours postoperatively
Placebo (x4)Drug
Given in 6 hour intervals the first 24 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: | Active comparator | Paracetamol 1g + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative. Receives: Drug: Paracetamol (1g x 4); Drug: Ibuprofen (400 mg x 4) |
| Treatment B: | Active comparator | Paracetamol 1g + placebo orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative. Receives: Drug: Paracetamol (1g x 4); Drug: Placebo (x4) |
| Treatment C: | Active comparator | Placebo + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative. Receives: Drug: Ibuprofen (400 mg x 4); Drug: Placebo (x4) |
| Treatment D: | Active comparator | Paracetamol 0,5 g + ibuprofen 200 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative. Receives: Drug: Paracetamol (0,5 g x 4); Drug: Ibuprofen (200 mg x 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption the first 24 hours postoperatively
Total need for morphine administered as BOTH patient controlled analgesia (PCA) for the first 24 hours postoperatively AND supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively. Bolus 2.0 mg; lockout: 10 min
Measured: 0-24 hours postoperatively
Serious adverse events
Serious adverse events, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except "prolongation of hospitalisation"
Measured: 0-90 days postoperatively
Secondary outcomes (5)
Pain during movement at 6 hours postoperatively (visual analogue scale)
Pain scores (visual analogue scale (VAS)) with active 30 degrees flexion of the hip at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100
Measured: 6 hours postoperatively
Pain during movement at 24 hours postoperatively (visual analogue scale)
Pain scores (visual analogue scale (VAS)) with active 30 degrees flexion of the hip at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100
Measured: 24 hours postoperatively
Pain at rest at 6 hours postoperatively (visual analogue scale)
Pain scores (visual analogue scale (VAS)) at rest at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100
Measured: 6 hours postoperatively
Pain at rest at 24 hours postoperatively (visual analogue scale)
Pain scores (visual analogue scale (VAS)) at rest at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100
Measured: 24 hours postoperatively
Adverse events
Number of patients with one or more adverse events in the intervention period (0-24 hours)
Measured: 0-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Hägi-Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Daniel Hägi-Pedersen, Naestved Hospital
- Investigators
- Daniel Hägi-Pedersen, MD, PhD, Study chair, Department of Anaesthesiology, Næstved HospitalKasper H Thybo, MD, Principal investigator, Department of Anaesthesiology, Næstved HospitalOle Mathiesen, MD, PhD, Study chair, Department of Anaesthesiology, Køge HospitalJørgen B Dahl, MD, DMSc, Study chair, Department of Anaesthesiology, Bispebjerg HospitalJørn Wetterslev, MD, PhD, Study chair, Copenhagen Trial Unit, Center for Clinical Intervention ResearchMartin Pohlman, MD, Study chair, Department of Anaesthesiology, Nykøbing Falster HospitalHans Henrik Bülow, MD, Study chair, Department of Anaesthesiology, Holbæk Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571361
- Sponsor's protocol ID
- SM2-KHT-2015 - v2
- Other IDs
- 2015-002239-16, 2015
- Acronym
- PANSAID
- Status last verified
- Feb 2018
- First submitted
- 7 Oct 2015
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Thybo KH, Hagi-Pedersen D, Wetterslev J, Dahl JB, Schroder HM, Bulow HH, Bjorck JG, Mathiesen O. PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial. Trials. 2017 Jan 10;18(1):11. doi: 10.1186/s13063-016-1749-7.
PubMed 28069072Thybo KH, Hagi-Pedersen D, Dahl JB, Wetterslev J, Nersesjan M, Jakobsen JC, Pedersen NA, Overgaard S, Schroder HM, Schmidt H, Bjorck JG, Skovmand K, Frederiksen R, Buus-Nielsen M, Sorensen CV, Kruuse LS, Lindholm P, Mathiesen O. Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial. JAMA. 2019 Feb 12;321(6):562-571. doi: 10.1001/jama.2018.22039.
PubMed 30747964Thybo KH, Jakobsen JC, Hagi-Pedersen D, Pedersen NA, Dahl JB, Schroder HM, Bulow HH, Bjorck JG, Overgaard S, Mathiesen O, Wetterslev J. PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial. Trials. 2017 Oct 10;18(1):465. doi: 10.1186/s13063-017-2203-1.
PubMed 29017585
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial
- ClinicalTrials.gov ID
- NCT02571361
- Acronym / sponsor ID
- PANSAID / SM2-KHT-2015 - v2
- Conditions
- Pain, Postoperative
- Keywords
- Acetaminophen, Ibuprofen, Arthroplasty, Replacement, Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Daniel Hägi-PedersenUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- Nov 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Oct 2015 (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.
Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial
Trial acronym: PANSAID
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.
Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.
Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.
Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.
Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.
Detailed description
Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial
Trial acronym: PANSAID
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.
Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.
Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.
Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.
Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.
Sub-studies: We preplan the following sub-studies. :
- A subgroup analysis of benefit outcomes (pain and opioid consumption) with respect to the following sub-groups: sex, age (below vs above 65 years old), ASA-score (I+II vs III), Use of analgesic medication before surgery (none vs any) and anaesthetic technique (general anaesthesia vs. spinal anaesthesia). Please find a detailed protocol at www.pansaid.dk
- A subgroup analysis of harm (serious adverse events and adverse events) with respect to the following groups sex, age (below vs above 65 years old), use of NSAIDs before surgery, and ASA-score (I+II vs III). Please find a detailed protocol at www.pansaid.dk
- Longer follow-up than the specified 90 days (1 year)
- An analysis of the association between VAS-scores and opioid consumption
- Time-to-event analyses regarding use of PCA-morphine
- An analysis of the association between preoperative analgesic use and pain/morphine consumption
- An analysis of the individual patients: how many will achieve "no worse than mild pain" (NRS<3). Please find a detailed protocol at www.pansaid.dk
More sub-studies may be performed post-hoc and they will be clearly identified as such.
Oversight of amendments and approvals Protocol version 2: Approved 12 August 2015: First approved version of the trial protocol
Protocol version 3: Approved 21 January 2016: Clarification of what happens in case of an SAE and definition of major protocol violations
Protocol version 4: Approved 15 June 2016: Clarification of the primary outcome, clarification that steroids are not permitted in the intervention period, and addition of an exploratory outcome (dizziness)
Protocol version 5: Approved 21 December 2016: Clarification of the exclusion criteria of contraindication to paracetamol and addition of stub-studies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A: | Active comparator | Drug: Paracetamol (1g x 4), Drug: Ibuprofen (400 mg x 4)Paracetamol 1g + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative. |
| Treatment B: | Active comparator | Drug: Paracetamol (1g x 4), Drug: Placebo (x4)Paracetamol 1g + placebo orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative. |
| Treatment C: | Active comparator | Drug: Ibuprofen (400 mg x 4), Drug: Placebo (x4)Placebo + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative. |
| Treatment D: | Active comparator | Drug: Paracetamol (0,5 g x 4), Drug: Ibuprofen (200 mg x 4)Paracetamol 0,5 g + ibuprofen 200 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled for unilateral, primary Total Hip Arthroplasty (THA)
- Age > 18
- ASA 1-3.
- BMI > 18 and < 40
- Women in the fertile age must have negative urine HCG pregnancy test
Key exclusion criteria (7 listed)
- Patients who cannot cooperate with the trial.
- Concomitant participation in another trial
- Patients who cannot understand or speak Danish.
- Daily use of strong opioids (tramadol and codein are accepted)
- Patients with allergy to the medicines used in the trial.
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 |
|---|---|---|
| Paracetamol (1g x 4)Also: AcetaminophenDose of 1 g given in 6 hour intervals the first 24 hours postoperatively | Drug | Treatment A:, Treatment B: |
| Ibuprofen (400 mg x 4)Dose of 400 mg given in 6 hour intervals the first 24 hours postoperatively | Drug | Treatment A:, Treatment C: |
| Paracetamol (0,5 g x 4)Also: AcetaminophenDose of 0,5 g given in 6 hour intervals the first 24 hours postoperatively | Drug | Treatment D: |
| Ibuprofen (200 mg x 4)Dose of 200 mg given in 6 hour intervals the first 24 hours postoperatively | Drug | Treatment D: |
| Placebo (x4)Given in 6 hour intervals the first 24 hours postoperatively | Drug | Treatment B:, Treatment C: |
Primary outcome
Morphine consumption the first 24 hours postoperatively
Time frame: 0-24 hours postoperatively
Total need for morphine administered as BOTH patient controlled analgesia (PCA) for the first 24 hours postoperatively AND supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively. Bolus 2.0 mg; lockout: 10 min
Serious adverse events
Time frame: 0-90 days postoperatively
Serious adverse events, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except "prolongation of hospitalisation"
5 secondary outcomes
Pain during movement at 6 hours postoperatively (visual analogue scale)
Time frame: 6 hours postoperatively
Pain during movement at 24 hours postoperatively (visual analogue scale)
Time frame: 24 hours postoperatively
Pain at rest at 6 hours postoperatively (visual analogue scale)
Time frame: 6 hours postoperatively
Pain at rest at 24 hours postoperatively (visual analogue scale)
Time frame: 24 hours postoperatively
Adverse events
Time frame: 0-24 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 12 Feb 2018.
- Background: PubMed 28069072Thybo KH, Hagi-Pedersen D, Wetterslev J, Dahl JB, Schroder HM, Bulow HH, Bjorck JG, Mathiesen O. PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial. Trials. 2017 Jan 10;18(1):11. doi: 10.1186/s13063-016-1749-7.
- Derived from this study: PubMed 30747964Thybo KH, Hagi-Pedersen D, Dahl JB, Wetterslev J, Nersesjan M, Jakobsen JC, Pedersen NA, Overgaard S, Schroder HM, Schmidt H, Bjorck JG, Skovmand K, Frederiksen R, Buus-Nielsen M, Sorensen CV, Kruuse LS, Lindholm P, Mathiesen O. Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial. JAMA. 2019 Feb 12;321(6):562-571. doi: 10.1001/jama.2018.22039.
- Derived from this study: PubMed 29017585Thybo KH, Jakobsen JC, Hagi-Pedersen D, Pedersen NA, Dahl JB, Schroder HM, Bulow HH, Bjorck JG, Overgaard S, Mathiesen O, Wetterslev J. PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial. Trials. 2017 Oct 10;18(1):465. doi: 10.1186/s13063-017-2203-1.
- Trial WebsiteLink provided by the sponsor.
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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.
Daniel Hägi-Pedersen, MD, PhD study chair
Department of Anaesthesiology, Næstved Hospital
Kasper H Thybo, MD principal investigator
Department of Anaesthesiology, Næstved Hospital
Ole Mathiesen, MD, PhD study chair
Department of Anaesthesiology, Køge Hospital
6 sites 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 (1g x 4), Ibuprofen (400 mg x 4) and Paracetamol (0,5 g x 4) in people with Pain, Postoperative, run by Daniel Hägi-Pedersen at 6 sites in Denmark.
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 6 inclusion and 7 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 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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?
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?
Morphine consumption the first 24 hours postoperatively (time frame: 0-24 hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT02571361, which also lists 3 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 12 Feb 2018.