Analgesic Effect of Parecoxib Versus Morphine in SCD Patients Presenting to the Emergency Department

NCT06315920 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: AFMS-MREC 009/2021
• Study Type: interventional
• Target: 226
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sickle-Cell Disease with Crisis

Keywords

SCD, Parecoxib , Opioids

Outcome Measures

Primary Outcomes (1)

• Pain reduction at 60 mins.

  analgesics effect of Parecoxib versus Morphine in sickle cell disease vaso- occlusive crisis.

  60 mintues

Secondary Outcomes (3)

• Adverse Events/Side Effects

  48 hours

• The need of rescue pain medications

  60 mintues

• Recurrent visit

  48 hours

Study Arms (2)

Parecoxib

EXPERIMENTAL

40mg of IV Parecoxib

Drug: Parecoxib

Morphine

ACTIVE COMPARATOR

5 mg of IV Morphine

Drug: Morphine

Interventions

Parecoxib DRUG

Single dose of 40mg of IV Parecoxib.

Also known as: a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID)

Parecoxib

Morphine DRUG

Single dose of 5 mg of IV Morphine.

Also known as: Morphine Sulfate

Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oman Medical Speciality Board: lead
• Armed Forces Hospital, Oman: collaborator

Related Publications (7)

• 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.

  PMID: 24386899 BACKGROUND

• 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.

  PMID: 33197808 BACKGROUND

• 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.

  PMID: 11808971 BACKGROUND

• 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.

  PMID: 12083587 BACKGROUND

• 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.

  PMID: 31924632 BACKGROUND

• 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.

  PMID: 28525512 BACKGROUND

• 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.

  PMID: 23587455 BACKGROUND

MeSH Terms

Conditions

Vaso-Occlusive Crises

Interventions

parecoxib; Morphine

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• USAMA ALKHALASI, MD

  Armed Forces Hospital, Oman

  STUDY CHAIR

• Muzna Al Sawafi, MD

  Armed Forces Hospital, Oman

  PRINCIPAL INVESTIGATOR

Central Study Contacts

USAMA ALKHALASI, MD

CONTACT

+96894094001; u.alkhalasi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The masking process involves the following steps: Preparation of Medication: A nurse, who is not involved in the direct care or assessment of the patients, will prepare the medications. This nurse is the only individual aware of the specific treatment being administered to each patient. The medications are prepared in a manner that makes them indistinguishable from each other in appearance, labeling, and administration method. Administration of Medication: The medications are then administered to the patients by healthcare providers who are blinded to the nature of the medication. This ensures that their assessment of the patient's response is not influenced by knowledge of the treatment being given. Assessment and Data Collection: The assessment of pain relief, side effects, and other relevant clinical outcomes is conducted by healthcare providers who are blinded to the treatment allocation. This minimizes bias in the evaluation of the treatment's efficacy and safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EM Specialist

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share