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

ConditionSickle-Cell Disease with Crisis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOman Medical Speciality Board

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Parecoxib

    Drug

    Single dose of 40mg of IV Parecoxib.

  • Morphine

    Drug

    Single dose of 5 mg of IV Morphine.

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: ParecoxibExperimental treatment 1 intervention
Group B: MorphineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain reduction at 60 mins.

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

Time frame
60 mintues

Secondary outcomes

1

Adverse Events/Side Effects

Any reported adverse events reported by subjects or attending doctor

Time frame
48 hours
2

The need of rescue pain medications

After 60 min , patients can have rescue medications as standard of care.

Time frame
60 mintues
3

Recurrent visit

Any recurrent visit with painful vaso- occlusive crisis

Time frame
48 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oman Medical Speciality Board

Lead sponsor

Armed Forces Hospital, Oman

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: