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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-01

Study Completion Date

2028-07-01

Brief Summary

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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.

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Detailed Description

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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

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Sickle-Cell Disease with Crisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Parecoxib

40mg of IV Parecoxib

Group Type EXPERIMENTAL

Parecoxib

Intervention Type DRUG

Single dose of 40mg of IV Parecoxib.

Morphine

5 mg of IV Morphine

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Single dose of 5 mg of IV Morphine.

Interventions

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Parecoxib

Single dose of 40mg of IV Parecoxib.

Intervention Type DRUG

Morphine

Single dose of 5 mg of IV Morphine.

Intervention Type DRUG

Other Intervention Names

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a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) Morphine Sulfate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes