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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756504
• Other study ID #: HMC-QAD-F-1202
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 22, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: April 2023
• Source: Hayatabad Medical Complex
• Contact: Musarrat Hussain
• Phone: 00923339212173
• Email: drmusarrat9740[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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

Locations

Country	Name	City	State
Pakistan	Hayatabad Medical Complex	Peshawar	Kpk

Sponsors (1)

Lead Sponsor	Collaborator
Hayatabad Medical Complex

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	time to pain relief	How much time did it take for the pain to relieve completely. (In hours)	0-24 hours
Secondary	adverse events	any adverse events with the drug intervention will be noted	0-24 hours
Secondary	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