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

NCT05756504 | Unknown Early Phase 1 DMC

• 1 other identifier: HMC-QAD-F-1202
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

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

Drug: Ketorolac

Opioids

EXPERIMENTAL

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

Drug: Tramadol

Interventions

Ketorolac DRUG

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

NSAIDs

Tramadol 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

Opioids

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hayatabad Medical Complex: lead

Study Sites (1)

Hayatabad Medical Complex

Peshawar, Kpk, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

Ketorolac; Tramadol

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Rehman Ullah Jan

  Hayatabad Medical Complex

  STUDY CHAIR

Central Study Contacts

Musarrat Hussain

CONTACT

00923339212173; drmusarrat9740@gmail.com

Muhammad Jawad Zahid

CONTACT

00923369957148; dr.jawadzahid@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: February 22, 2023
• Primary Completion: January 20, 2024
• Study Completion: February 20, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years
• Access Criteria: The data will be shared on request by the institution

Locations

PA (1)