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

NCT06315920 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2025-03-20

No results posted yet for this study

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

Interventions

DRUG

Parecoxib

Single dose of 40mg of IV Parecoxib.

DRUG

Morphine

Single dose of 5 mg of IV Morphine.

Sponsors & Collaborators

  • Armed Forces Hospital, Oman

    collaborator UNKNOWN

  • Oman Medical Speciality Board

    lead OTHER_GOV

Principal Investigators

  • USAMA ALKHALASI, MD · Armed Forces Hospital, Oman

  • Muzna Al Sawafi, MD · Armed Forces Hospital, Oman

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-05-01
Completion
2028-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06315920 on ClinicalTrials.gov