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

Primary Purpose

Acute Pancreatitis

Status
Recruiting
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Ketorolac
Tramadol
Sponsored by
Hayatabad Medical Complex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hayatabad Medical ComplexRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NSAIDs

Opioids

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
time to pain relief
How much time did it take for the pain to relieve completely. (In hours)
adverse events
any adverse events with the drug intervention will be noted
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.

Full Information

First Posted
February 22, 2023
Last Updated
April 5, 2023
Sponsor
Hayatabad Medical Complex
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1. Study Identification

Unique Protocol Identification Number
NCT05756504
Brief Title
"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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hayatabad Medical Complex

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NSAIDs
Arm Type
Experimental
Arm Description
Patients in this arm will be given ketorolac injection 30 mg IV x TDS for pain management of mild to moderate acute pancreatitis
Arm Title
Opioids
Arm Type
Experimental
Arm Description
Patients in this arm will be given injection tramadol IV x TDS for pain management of mild to moderate acute pancreatitis
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
Injection ketorolac 30 mg IV x TDS will be given to each patient in each group.
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Injection Tramadol 25-50 mg IV x TDs wil be given to each patient in this group. Maximum dose will be 400 mg/ day
Primary Outcome Measure Information:
Title
Pain Intensity at 2 hours
Description
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
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Pain intensity at 4, 6, 8, and 24 hours after the intervention
Description
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
Time Frame
4-24 hours
Title
time to pain relief
Description
How much time did it take for the pain to relieve completely. (In hours)
Time Frame
0-24 hours
Title
adverse events
Description
any adverse events with the drug intervention will be noted
Time Frame
0-24 hours
Title
patient satisfaction with pain management.
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Musarrat Hussain
Phone
00923339212173
Email
drmusarrat9740@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Jawad Zahid
Phone
00923369957148
Email
dr.jawadzahid@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehman Ullah Jan
Organizational Affiliation
Hayatabad Medical Complex
Official's Role
Study Chair
Facility Information:
Facility Name
Hayatabad Medical Complex
City
Peshawar
State/Province
Kpk
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Musarrat Hussain
Phone
00923339212173
Email
drmusarrat9740@gmail.com
First Name & Middle Initial & Last Name & Degree
Muhammad Jawad Zahid
Phone
00923369957148
Email
dr.jawadzahid@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
The data will be shared on request by the institution

Learn more about this trial

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

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