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

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

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 Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Drug: Ketorolac; Drug: Tramadol

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Musarrat Hussain; Phone Number: 00923339212173; Email: drmusarrat9740@gmail.com
• Study Contact Backup: Name: Muhammad Jawad Zahid; Phone Number: 00923369957148; Email: dr.jawadzahid@yahoo.com

Study Locations

• Pakistan
  • Kpk
    • Peshawar, Kpk, Pakistan, 25000
      • Recruiting
      • Hayatabad Medical Complex
      • Contact: Musarrat Hussain; Phone Number: 00923339212173; Email: drmusarrat9740@gmail.com
      • Contact: Muhammad Jawad Zahid; Phone Number: 00923369957148; Email: dr.jawadzahid@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NSAIDs; Patients in this arm will be given ketorolac injection 30 mg IV x TDS for pain management of mild to moderate acute pancreatitis	Drug: Ketorolac; Injection ketorolac 30 mg IV x TDS will be given to each patient in each group.
Experimental: Opioids; Patients in this arm will be given injection tramadol IV x TDS for pain management of mild to moderate acute pancreatitis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity at 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	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity at 4, 6, 8, and 24 hours after the intervention	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". Pain intensity will be measured at NRS scale at 4, 6, 8 and 24 hours after the intervention and recorded accordingly	4-24 hours
time to pain relief	How much time did it take for the pain to relieve completely. (In hours)	0-24 hours
adverse events	any adverse events with the drug intervention will be noted	0-24 hours
patient satisfaction with pain management.	In this study, patient satisfaction with pain management will be assessed using a modified version of the Likert scale. Participants will be asked to rate their satisfaction with pain management on a scale from 1 to 5, where 1 is "very dissatisfied," 2 is "somewhat dissatisfied," 3 is "neither satisfied nor dissatisfied," 4 is "somewhat satisfied," and 5 is "very satisfied." This scale will be administered at 24 hours after the intervention. The satisfaction scale will also include an open-ended question to allow patients to provide any comments or suggestions regarding their pain management experience. These comments can provide valuable insights into the patient experience and help to inform future pain management practices.	1 day

Collaborators and Investigators

• Sponsor: Hayatabad Medical Complex
• Investigators: Study Chair: Rehman Ullah Jan, Hayatabad Medical Complex

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Anticipated): January 20, 2024
• Study Completion (Anticipated): February 20, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Ketorolac; Tramadol
• Other Study ID Numbers: HMC-QAD-F-1202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 3 years
• IPD Sharing Access Criteria: The data will be shared on request by the institution
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No