Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-12
Brief Title:
Analgesic Effect of Parecoxib Versus Morphine in SCD Patients Presenting to the Emergency Department
Sponsor:
Oman Medical Speciality Board
Organization:
Oman Medical Speciality Board
Study Overview
Official Title:
Parecoxib Versus Morphine in Acute Pain Management for Sickle Cell Disease Patients in Emergency Department A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASC
Brief 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
Objectives
Primary Evaluate the analgesic effect of Paracoxib versus Morphine in SCD vaso-occlusive crises
Secondary Reduce opioid usedependence 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
Objectives
Primary Evaluate the analgesic effect of Paracoxib versus Morphine in SCD vaso-occlusive crises
Secondary Reduce opioid usedependence 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 Parecoxibs 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 opioidNSAID 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 studys 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
Background Recent studies have highlighted Parecoxibs 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 opioidNSAID 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 studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None