Clinical trial NCT05756504: "NSAIDs vs. Opiates: Which is More Effective in Managing Pain in Mild to Moderate Acute Pancreatitis?
Official title: "NSAIDs vs. Opiates: Which is More Effective in Managing Pain in Mild to Moderate Acute Pancreatitis? A Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Acute Pancreatitis
Lead sponsor: Hayatabad Medical Complex
Sponsor class: OTHER_GOV
First posted: 2023-03-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity at 2 hours
timeFrame: 2 hours
Secondary outcomes:
measure: Pain intensity at 4, 6, 8, and 24 hours after the intervention
timeFrame: 4-24 hours
measure: time to pain relief
timeFrame: 0-24 hours
measure: adverse events
timeFrame: 0-24 hours
measure: patient satisfaction with pain management.
timeFrame: 1 day
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Hayatabad Medical Complex
state: Kpk
Study officials:
affiliation: Hayatabad Medical Complex
name: Rehman Ullah Jan
role: STUDY_CHAIR
References: