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Clinical Trials/NCT05756504
NCT05756504RecruitingEarly Phase 1

"NSAIDs vs. Opiates: Which is More Effective in Managing Pain in Mild to Moderate Acute Pancreatitis? A Randomized Controlled Trial"

Hayatabad Medical Complex1 site in 1 country130 target enrollmentStarted: February 22, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Recruiting
Enrollment
130
Locations
1
Primary Endpoint
Pain Intensity at 2 hours

Study Overview

Brief Summary

Acute pancreatitis is a painful and potentially life-threatening condition that affects the pancreas, a glandular organ responsible for producing digestive enzymes and hormones. The condition is typically characterized by sudden inflammation of the pancreas that can cause severe abdominal pain, nausea, and vomiting. Treatment for acute pancreatitis usually involves supportive care, pain management, and sometimes, hospitalization.

Nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are two of the most commonly used classes of pain medication for the management of acute pancreatitis. While both drugs are effective in reducing pain, they have different mechanisms of action and potential side effects. NSAIDs work by reducing inflammation and pain by inhibiting the activity of cyclooxygenase (COX) enzymes, whereas opioids work by binding to specific receptors in the brain and spinal cord to block the transmission of pain signals.

Despite their widespread use, there is a lack of consensus regarding which medication is more effective for the management of acute pancreatitis, particularly in mild to moderate cases. Some studies have suggested that NSAIDs may be more effective for reducing pain in acute pancreatitis, while others have suggested that opioids may be more effective in providing pain relief. Moreover, there is a concern regarding the potential for adverse events associated with the use of opioids, such as respiratory depression, addiction, and constipation.

Therefore, this study aims to compare the efficacy and safety of NSAIDs and opioids in the management of mild to moderate acute pancreatitis. This will be a randomized clinical trial, which will involve the recruitment of patients with mild to moderate acute pancreatitis who will be randomized to receive either an NSAID or an opioid for pain management. The primary outcome of this study will be the reduction in pain score measured using a visual analogue scale (VAS) over a 72-hour period. The secondary outcomes will include adverse events associated with each medication, length of hospital stay, and the need for further interventions.

This study has the potential to provide important insights into the optimal management of pain in mild to moderate acute pancreatitis, which can ultimately improve patient outcomes and reduce the burden of this condition on the healthcare system.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18 years or older
  • Diagnosis of mild to moderate acute pancreatitis based on clinical and radiological criteria
  • Moderate pain intensity (NRS score of 4-7)
  • No history of allergy or intolerance to NSAIDs or opiates
  • No history of opioid abuse or addiction

Exclusion Criteria

  • Severe acute pancreatitis requiring intensive care unit admission
  • Pregnancy or lactation
  • History of significant renal or hepatic dysfunction
  • Use of non-steroidal anti-inflammatory drugs or opiates in the past 24 hours
  • Known or suspected peptic ulcer disease
  • Known or suspected gastrointestinal bleeding
  • Participation in another clinical trial in the past 30 days
  • Inability to provide informed consent
  • Inability to communicate pain intensity using the numeric rating scale
  • Allergy or intolerance to any of the study medications or their components.

Arms & Interventions

NSAIDs

Experimental

Patients in this arm will be given ketorolac injection 30 mg IV x TDS for pain management of mild to moderate acute pancreatitis

Intervention: Ketorolac (Drug)

Opioids

Experimental

Patients in this arm will be given injection tramadol IV x TDS for pain management of mild to moderate acute pancreatitis

Intervention: Tramadol (Drug)

Outcomes

Primary Outcomes

Pain Intensity at 2 hours

Time Frame: 2 hours

The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". The primary outcome of this study is pain intensity measured on the NRS at 2 hours after the intervention

Secondary Outcomes

  • Pain intensity at 4, 6, 8, and 24 hours after the intervention(4-24 hours)
  • time to pain relief(0-24 hours)
  • adverse events(0-24 hours)
  • patient satisfaction with pain management.(1 day)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Musarrat Hussain

Assistant Professor, Department of Surgery

Hayatabad Medical Complex

Study Sites (1)

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