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

March 12, 2024 updated by: Usama Al-Khalasi, Oman Medical Speciality Board

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:

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

226

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parecoxib
40mg of IV Parecoxib
Drug: Parecoxib
Single dose of 40mg of IV Parecoxib.
Other Names:
  • a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID)
Active Comparator: Morphine
5 mg of IV Morphine
Drug: Morphine
Single dose of 5 mg of IV Morphine.
Other Names:
  • Morphine Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction at 60 mins.
Time Frame: 60 mintues
analgesics effect of Parecoxib versus Morphine in sickle cell disease vaso- occlusive crisis.
60 mintues

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events/Side Effects
Time Frame: 48 hours
Any reported adverse events reported by subjects or attending doctor
48 hours
The need of rescue pain medications
Time Frame: 60 mintues
After 60 min , patients can have rescue medications as standard of care.
60 mintues
Recurrent visit
Time Frame: 48 hours
Any recurrent visit with painful vaso- occlusive crisis
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oman Medical Speciality Board

Collaborators

Armed Forces Hospital, Oman

Investigators

  • Study Chair: USAMA ALKHALASI, MD, Armed Forces Hospital, Oman
  • Principal Investigator: Muzna Al Sawafi, MD, Armed Forces Hospital, Oman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFMS-MREC 009/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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