Sickle-Cell Disease with CrisisPhase 3PASCNCT06315920
Analgesic Effect of Parecoxib Versus Morphine in SCD Patients Presenting to the Emergency Department
A Phase 3 study testing Parecoxib and Morphine in people with Sickle-Cell Disease with Crisis, run by Oman Medical Speciality Board.
Trial summary
Introduction: This study focuses on the treatment of painful crises in Sickle Cell Disease (SCD) patients using Paracoxib, a non-opioid, compared to Morphine. It addresses the need for alternative medications that reduce opioid dependency while providing effective analgesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle-Cell Disease with Crisis
- What is being tested?
- Parecoxib and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Jul 2028
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- An adult (>18 years) sickle cell disease patient presents with moderate-severe vaso-occlusive crisis (VOC) to the ED.
Who cannot join
- Non-VOC Pain (e.g. Acute chest syndrome, sequestration, septic arthritis, Etc.)
- Weight less than 50 KG
- Recurrent visits > one visit/ week
- Opioids within 24hrs
- NSAIDs within 24hrs
- Contraindications to NSAIDs (e.g. allergy, Asthma, CKD, pregnancy, Etc.)
- Lactating mothers
- Visited another health institution within 24hrs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Parecoxib Versus Morphine in Acute Pain Management for Sickle Cell Disease Patients in Emergency Department: a Randomized Controlled Trial.
Introduction: This study focuses on the treatment of painful crises in Sickle Cell Disease (SCD) patients using Paracoxib, a non-opioid, compared to Morphine. It addresses the need for alternative medications that reduce opioid dependency while providing effective analgesia.
Objectives:
Read more
Primary: Evaluate the analgesic effect of Paracoxib versus Morphine in SCD vaso-occlusive crises.
Secondary: Reduce opioid use/dependence, decrease the length of hospital stays, and monitor side effects related to Paracoxib.
Methodology: A double-blinded randomized controlled trial, conducted in a tertiary care emergency department. The study includes adult SCD patients with moderate to severe crises, excluding non-VOC pain, certain medications, and specific medical conditions. The sample size is 226 patients, split equally into two groups.
Intervention: Patients receive either Morphine or Paracoxib, with periodic assessment of vital signs and pain. Additional Morphine is administered if required. Data collection and analysis are meticulously planned.
Expected Outcomes: Improvement in SCD pain management, reduction in opioid usage, and potential benefits in terms of hospital stays and patient satisfaction.
Read the detailed description
Introduction: Sickle Cell Disease (SCD) is a prevalent hematological disorder in Oman. Patients frequently present to Emergency Departments (ED) with painful crises, often requiring high doses of opioids like Morphine. However, the complications associated with opioid use, including dependency, necessitate exploring alternative analgesic options. This research proposes a comparative study of Parecoxib, a non-steroidal anti-inflammatory drug (NSAID), and Morphine in managing pain for SCD patients in the ED.
Background: Recent studies have highlighted Parecoxib's potential in various clinical settings. In trauma patients, Parecoxib demonstrated comparable analgesic efficacy to Morphine, suggesting its broader applicability in the ED. Parecoxib has shown benefits in post-operative pain management, reducing opioid requirements and associated adverse events. Notably, in post knee replacement surgeries, Parecoxib effectively managed pain and facilitated functional recovery. It also contributed to decreased postoperative delirium in elderly patients undergoing hip or knee replacement surgery without increasing adverse events.
Research Objectives: The primary objective of this study is to evaluate the analgesic efficacy of Parecoxib versus Morphine in SCD patients experiencing vaso-occlusive crises. Secondary objectives include assessing the potential reduction in opioid dependence, length of hospital stay, recurrence of ED visits, and monitoring any Parecoxib-related side effects in SCD patients.
Methodology:
- Study Design: A double-blinded, randomized controlled trial.
- Study Setting: AFH Emergency Department, a tertiary care institution.
- Target Population: Adult SCD patients (>18 years) presenting with moderate to severe vaso-occlusive crises.
- Exclusion Criteria: Include non-VOC pain, weight < 50 kg, frequent ED visits, recent opioid/NSAID use, contraindications to NSAIDs, lactating mothers, and recent visits to other health institutions.
- Sample Size: The sample size of 226 patients, split into two groups of 113 each, was determined for a two-sided hypothesis test with a 5% significance level and 90% power. This design ensures a high probability of detecting a significant difference in the analgesic efficacy between Parecoxib and Morphine for SCD patients. The calculated size is based on expected effect sizes from previous research, with additional allowance for potential dropouts, ensuring the study's statistical validity and comprehensiveness.
- Intervention: Computer-randomized administration of Morphine or Parecoxib. Continuous monitoring of vital signs and pain assessment at set intervals post-medication administration. Senior emergency physicians and residents will conduct assessments.
- Data Collection and Analysis: The study will be double-blinded, with only the preparing nurse aware of the medication used. Data will be recorded using Epi-Data and analyzed using SPSS version 25.
Expected Outcomes: The study aims to enhance pain management protocols for SCD patients in the ED. By introducing Parecoxib as an alternative to opioids, we anticipate reduced opioid use, shortened hospital stays, fewer ED visits, and overall cost-effectiveness in managing SCD pain crises. The findings will be disseminated through local and international conferences and journals.
- Conditions
- Sickle-Cell Disease with Crisis
- Being tested
- Parecoxib, Morphine
- Keywords
- SCD, Parecoxib , Opioids
- Medical subject headings
- Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
Also called a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID)
Single dose of 40mg of IV Parecoxib.
MorphineDrug
Also called Morphine Sulfate
Single dose of 5 mg of IV Morphine.
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib | Experimental | 40mg of IV Parecoxib Receives: Drug: Parecoxib |
| Morphine | Active comparator | 5 mg of IV Morphine Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction at 60 mins.
analgesics effect of Parecoxib versus Morphine in sickle cell disease vaso- occlusive crisis.
Measured: 60 mintues
Secondary outcomes (3)
Adverse Events/Side Effects
Any reported adverse events reported by subjects or attending doctor
Measured: 48 hours
The need of rescue pain medications
After 60 min , patients can have rescue medications as standard of care.
Measured: 60 mintues
Recurrent visit
Any recurrent visit with painful vaso- occlusive crisis
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sickle-Cell Disease with CrisisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Collaborators
- Armed Forces Hospital, Oman
- Responsible party
- Principal investigator, Usama Al-Khalasi, Oman Medical Speciality Board
- Investigators
- USAMA ALKHALASI, MD, Study chair, Armed Forces Hospital, OmanMuzna Al Sawafi, MD, Principal investigator, Armed Forces Hospital, Oman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315920
- Sponsor's protocol ID
- AFMS-MREC 009/2021
- Acronym
- PASC
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baharuddin KA, Rahman NH, Wahab SF, Halim NA, Ahmad R. Intravenous parecoxib sodium as an analgesic alternative to morphine in acute trauma pain in the emergency department. Int J Emerg Med. 2014 Jan 3;7(1):2. doi: 10.1186/1865-1380-7-2.
PubMed 24386899Laoruengthana A, Rattanaprichavej P, Reosanguanwong K, Chinwatanawongwan B, Chompoonutprapa P, Pongpirul K. A randomized controlled trial comparing the efficacies of ketorolac and parecoxib for early pain management after total knee arthroplasty. Knee. 2020 Dec;27(6):1708-1714. doi: 10.1016/j.knee.2020.10.005. Epub 2020 Nov 13.
PubMed 33197808Stoltz RR, Harris SI, Kuss ME, LeComte D, Talwalker S, Dhadda S, Hubbard RC. Upper GI mucosal effects of parecoxib sodium in healthy elderly subjects. Am J Gastroenterol. 2002 Jan;97(1):65-71. doi: 10.1111/j.1572-0241.2002.05265.x.
PubMed 11808971Rasmussen GL, Steckner K, Hogue C, Torri S, Hubbard RC. Intravenous parecoxib sodium foracute pain after orthopedic knee surgery. Am J Orthop (Belle Mead NJ). 2002 Jun;31(6):336-43.
PubMed 12083587Zhuang Q, Tao L, Lin J, Jin J, Qian W, Bian Y, Li Y, Dong Y, Peng H, Li Y, Fan Y, Wang W, Feng B, Gao N, Sun T, Lin J, Zhang M, Yan S, Shen B, Pei F, Weng X. Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial. BMJ Open. 2020 Jan 9;10(1):e030501. doi: 10.1136/bmjopen-2019-030501.
PubMed 31924632Mu DL, Zhang DZ, Wang DX, Wang G, Li CJ, Meng ZT, Li YW, Liu C, Li XY. Parecoxib Supplementation to Morphine Analgesia Decreases Incidence of Delirium in Elderly Patients After Hip or Knee Replacement Surgery: A Randomized Controlled Trial. Anesth Analg. 2017 Jun;124(6):1992-2000. doi: 10.1213/ANE.0000000000002095.
PubMed 28525512Nong L, Sun Y, Tian Y, Li H, Li H. Effects of parecoxib on morphine analgesia after gynecology tumor operation: a randomized trial of parecoxib used in postsurgical pain management. J Surg Res. 2013 Aug;183(2):821-6. doi: 10.1016/j.jss.2013.02.059. Epub 2013 Mar 30.
PubMed 23587455
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parecoxib Versus Morphine in Acute Pain Management for Sickle Cell Disease Patients in Emergency Department: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06315920
- Acronym / sponsor ID
- PASC / AFMS-MREC 009/2021
- Conditions
- Sickle-Cell Disease with Crisis
- Keywords
- SCD, Parecoxib , Opioids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Collaborators
- Armed Forces Hospital, Oman
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 18 Mar 2024 (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.
Introduction: This study focuses on the treatment of painful crises in Sickle Cell Disease (SCD) patients using Paracoxib, a non-opioid, compared to Morphine. It addresses the need for alternative medications that reduce opioid dependency while providing effective analgesia.
Objectives:
Primary: Evaluate the analgesic effect of Paracoxib versus Morphine in SCD vaso-occlusive crises.
Secondary: Reduce opioid use/dependence, decrease the length of hospital stays, and monitor side effects related to Paracoxib.
Methodology: A double-blinded randomized controlled trial, conducted in a tertiary care emergency department. The study includes adult SCD patients with moderate to severe crises, excluding non-VOC pain, certain medications, and specific medical conditions. The sample size is 226 patients, split equally into two groups.
Intervention: Patients receive either Morphine or Paracoxib, with periodic assessment of vital signs and pain. Additional Morphine is administered if required. Data collection and analysis are meticulously planned.
Expected Outcomes: Improvement in SCD pain management, reduction in opioid usage, and potential benefits in terms of hospital stays and patient satisfaction.
Detailed description
Introduction: Sickle Cell Disease (SCD) is a prevalent hematological disorder in Oman. Patients frequently present to Emergency Departments (ED) with painful crises, often requiring high doses of opioids like Morphine. However, the complications associated with opioid use, including dependency, necessitate exploring alternative analgesic options. This research proposes a comparative study of Parecoxib, a non-steroidal anti-inflammatory drug (NSAID), and Morphine in managing pain for SCD patients in the ED.
Background: Recent studies have highlighted Parecoxib's potential in various clinical settings. In trauma patients, Parecoxib demonstrated comparable analgesic efficacy to Morphine, suggesting its broader applicability in the ED. Parecoxib has shown benefits in post-operative pain management, reducing opioid requirements and associated adverse events. Notably, in post knee replacement surgeries, Parecoxib effectively managed pain and facilitated functional recovery. It also contributed to decreased postoperative delirium in elderly patients undergoing hip or knee replacement surgery without increasing adverse events.
Research Objectives: The primary objective of this study is to evaluate the analgesic efficacy of Parecoxib versus Morphine in SCD patients experiencing vaso-occlusive crises. Secondary objectives include assessing the potential reduction in opioid dependence, length of hospital stay, recurrence of ED visits, and monitoring any Parecoxib-related side effects in SCD patients.
Methodology:
- Study Design: A double-blinded, randomized controlled trial.
- Study Setting: AFH Emergency Department, a tertiary care institution.
- Target Population: Adult SCD patients (>18 years) presenting with moderate to severe vaso-occlusive crises.
- Exclusion Criteria: Include non-VOC pain, weight < 50 kg, frequent ED visits, recent opioid/NSAID use, contraindications to NSAIDs, lactating mothers, and recent visits to other health institutions.
- Sample Size: The sample size of 226 patients, split into two groups of 113 each, was determined for a two-sided hypothesis test with a 5% significance level and 90% power. This design ensures a high probability of detecting a significant difference in the analgesic efficacy between Parecoxib and Morphine for SCD patients. The calculated size is based on expected effect sizes from previous research, with additional allowance for potential dropouts, ensuring the study's statistical validity and comprehensiveness.
- Intervention: Computer-randomized administration of Morphine or Parecoxib. Continuous monitoring of vital signs and pain assessment at set intervals post-medication administration. Senior emergency physicians and residents will conduct assessments.
- Data Collection and Analysis: The study will be double-blinded, with only the preparing nurse aware of the medication used. Data will be recorded using Epi-Data and analyzed using SPSS version 25.
Expected Outcomes: The study aims to enhance pain management protocols for SCD patients in the ED. By introducing Parecoxib as an alternative to opioids, we anticipate reduced opioid use, shortened hospital stays, fewer ED visits, and overall cost-effectiveness in managing SCD pain crises. The findings will be disseminated through local and international conferences and journals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib | Experimental | Drug: Parecoxib40mg of IV Parecoxib |
| Morphine | Active comparator | Drug: Morphine5 mg of IV Morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- An adult (>18 years) sickle cell disease patient presents with moderate-severe vaso-occlusive crisis (VOC) to the ED.
Key exclusion criteria (8 listed)
- Non-VOC Pain (e.g. Acute chest syndrome, sequestration, septic arthritis, Etc.)
- Weight less than 50 KG
- Recurrent visits > one visit/ week
- Opioids within 24hrs
- NSAIDs within 24hrs
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 |
|---|---|---|
| ParecoxibAlso: a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID)Single dose of 40mg of IV Parecoxib. | Drug | Parecoxib |
| MorphineAlso: Morphine SulfateSingle dose of 5 mg of IV Morphine. | Drug | Morphine |
Primary outcome
Pain reduction at 60 mins.
Time frame: 60 mintues
analgesics effect of Parecoxib versus Morphine in sickle cell disease vaso- occlusive crisis.
3 secondary outcomes
Adverse Events/Side Effects
Time frame: 48 hours
The need of rescue pain medications
Time frame: 60 mintues
Recurrent visit
Time frame: 48 hours
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 20 Mar 2025.
- Background: PubMed 24386899Baharuddin KA, Rahman NH, Wahab SF, Halim NA, Ahmad R. Intravenous parecoxib sodium as an analgesic alternative to morphine in acute trauma pain in the emergency department. Int J Emerg Med. 2014 Jan 3;7(1):2. doi: 10.1186/1865-1380-7-2.
- Background: PubMed 33197808Laoruengthana A, Rattanaprichavej P, Reosanguanwong K, Chinwatanawongwan B, Chompoonutprapa P, Pongpirul K. A randomized controlled trial comparing the efficacies of ketorolac and parecoxib for early pain management after total knee arthroplasty. Knee. 2020 Dec;27(6):1708-1714. doi: 10.1016/j.knee.2020.10.005. Epub 2020 Nov 13.
- Background: PubMed 11808971Stoltz RR, Harris SI, Kuss ME, LeComte D, Talwalker S, Dhadda S, Hubbard RC. Upper GI mucosal effects of parecoxib sodium in healthy elderly subjects. Am J Gastroenterol. 2002 Jan;97(1):65-71. doi: 10.1111/j.1572-0241.2002.05265.x.
- Background: PubMed 12083587Rasmussen GL, Steckner K, Hogue C, Torri S, Hubbard RC. Intravenous parecoxib sodium foracute pain after orthopedic knee surgery. Am J Orthop (Belle Mead NJ). 2002 Jun;31(6):336-43.
- Background: PubMed 31924632Zhuang Q, Tao L, Lin J, Jin J, Qian W, Bian Y, Li Y, Dong Y, Peng H, Li Y, Fan Y, Wang W, Feng B, Gao N, Sun T, Lin J, Zhang M, Yan S, Shen B, Pei F, Weng X. Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial. BMJ Open. 2020 Jan 9;10(1):e030501. doi: 10.1136/bmjopen-2019-030501.
- Background: PubMed 28525512Mu DL, Zhang DZ, Wang DX, Wang G, Li CJ, Meng ZT, Li YW, Liu C, Li XY. Parecoxib Supplementation to Morphine Analgesia Decreases Incidence of Delirium in Elderly Patients After Hip or Knee Replacement Surgery: A Randomized Controlled Trial. Anesth Analg. 2017 Jun;124(6):1992-2000. doi: 10.1213/ANE.0000000000002095.
- Background: PubMed 23587455Nong L, Sun Y, Tian Y, Li H, Li H. Effects of parecoxib on morphine analgesia after gynecology tumor operation: a randomized trial of parecoxib used in postsurgical pain management. J Surg Res. 2013 Aug;183(2):821-6. doi: 10.1016/j.jss.2013.02.059. Epub 2013 Mar 30.
- Individual participant dataSharing planned: No
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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.
USAMA ALKHALASI, MD study chair
Armed Forces Hospital, Oman
Muzna Al Sawafi, MD principal investigator
Armed Forces Hospital, Oman
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Parecoxib and Morphine in people with Sickle-Cell Disease with Crisis, run by Oman Medical Speciality Board.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 USAMA ALKHALASI, MD (+96894094001, u.alkhalasi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction at 60 mins. (time frame: 60 mintues). 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 NCT06315920, which also lists 7 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 20 Mar 2025.