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

NCT ID: NCT05756504

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2024-02-20

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.

Conditions

Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NSAIDs

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

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

Injection ketorolac 30 mg IV x TDS will be given to each patient in each group.

Opioids

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

Group Type: EXPERIMENTAL

Tramadol

Intervention Type: DRUG

Injection Tramadol 25-50 mg IV x TDs wil be given to each patient in this group. Maximum dose will be 400 mg/ day

Interventions

Ketorolac

Injection ketorolac 30 mg IV x TDS will be given to each patient in each group.

Intervention Type: DRUG

Tramadol

Injection Tramadol 25-50 mg IV x TDs wil be given to each patient in this group. Maximum dose will be 400 mg/ day

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hayatabad Medical Complex

OTHER_GOV

Sponsor Role: lead

Responsible Party

Musarrat Hussain

Assistant Professor, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rehman Ullah Jan

Role: STUDY_CHAIR

Hayatabad Medical Complex

Locations

Hayatabad Medical Complex

Peshawar, Kpk, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Musarrat Hussain

Role: CONTACT

drmusarrat9740@gmail.com

00923339212173

Muhammad Jawad Zahid

Role: CONTACT

dr.jawadzahid@yahoo.com

00923369957148

Facility Contacts

Musarrat Hussain

Role: primary

drmusarrat9740@gmail.com

00923339212173

Muhammad Jawad Zahid

Role: backup

dr.jawadzahid@yahoo.com

00923369957148

Other Identifiers

HMC-QAD-F-1202

Identifier Type: -

Identifier Source: org_study_id