Clinical trial NCT06315920: Analgesic Effect of Parecoxib Versus Morphine in SCD Patients Presenting to the Emergency Department
Official title: Parecoxib Versus Morphine in Acute Pain Management for Sickle Cell Disease Patients in Emergency Department: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Sickle-Cell Disease with Crisis
Keywords: SCD, Parecoxib , Opioids
Lead sponsor: Oman Medical Speciality Board
Sponsor class: OTHER_GOV
Collaborators: name: Armed Forces Hospital, Oman
First posted: 2024-03-18
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* An adult (\>18 years) sickle cell disease patient presents with moderate-severe vaso-occlusive crisis (VOC) to the ED.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain reduction at 60 mins.
timeFrame: 60 mintues
Secondary outcomes:
measure: Adverse Events/Side Effects
timeFrame: 48 hours
measure: The need of rescue pain medications
timeFrame: 60 mintues
measure: Recurrent visit
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Armed Forces Hospital, Oman
name: USAMA ALKHALASI, MD
role: STUDY_CHAIR
affiliation: Armed Forces Hospital, Oman
name: Muzna Al Sawafi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Laoruengthana 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.
citation: Stoltz 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.
citation: Rasmussen 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.
citation: Zhuang 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.
citation: Mu 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.
citation: Nong 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.