Acute PancreatitisEarly Phase 1NCT05756504
"NSAIDs vs. Opiates: Which is More Effective in Managing Pain in Mild to Moderate Acute Pancreatitis?
A Early Phase 1 study testing Ketorolac and Tramadol in people with Acute Pancreatitis, run by Hayatabad Medical Complex at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Ketorolac and Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Feb 2023to 20 Feb 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Hayatabad Medical Complex
Peshawar, Kpk, 25000
Musarrat Hussain, 00923339212173, drmusarrat9740@gmail.com
Muhammad Jawad Zahid, 00923369957148, dr.jawadzahid@yahoo.com
About this study
Official title: "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.
Read more
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
- Being tested
- Ketorolac, Tramadol
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Injection ketorolac 30 mg IV x TDS will be given to each patient in each group.
TramadolDrug
Injection Tramadol 25-50 mg IV x TDs wil be given to each patient in this group. Maximum dose will be 400 mg/ day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (4)
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
Measured: 4-24 hours
time to pain relief
How much time did it take for the pain to relieve completely. (In hours)
Measured: 0-24 hours
adverse events
any adverse events with the drug intervention will be noted
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start22 Feb 2023
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Musarrat Hussain, Hayatabad Medical Complex
- Investigators
- Rehman Ullah Jan, Study chair, Hayatabad Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756504
- Sponsor's protocol ID
- HMC-QAD-F-1202
- Status last verified
- Apr 2023
- First submitted
- 22 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "NSAIDs vs. Opiates: Which is More Effective in Managing Pain in Mild to Moderate Acute Pancreatitis? A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT05756504
- Acronym / sponsor ID
- HMC-QAD-F-1202
- Conditions
- Acute Pancreatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hayatabad Medical ComplexOther government
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAIDs | Experimental | Drug: KetorolacPatients in this arm will be given ketorolac injection 30 mg IV x TDS for pain management of mild to moderate acute pancreatitis |
| Opioids | Experimental | Drug: TramadolPatients in this arm will be given injection tramadol IV x TDS for pain management of mild to moderate acute pancreatitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacInjection ketorolac 30 mg IV x TDS will be given to each patient in each group. | Drug | NSAIDs |
| TramadolInjection Tramadol 25-50 mg IV x TDs wil be given to each patient in this group. Maximum dose will be 400 mg/ day | Drug | Opioids |
Primary outcome
Pain Intensity at 2 hours
Time frame: 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
4 secondary outcomes
Pain intensity at 4, 6, 8, and 24 hours after the intervention
Time frame: 4-24 hours
time to pain relief
Time frame: 0-24 hours
adverse events
Time frame: 0-24 hours
patient satisfaction with pain management.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rehman Ullah Jan study chair
Hayatabad Medical Complex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketorolac and Tramadol in people with Acute Pancreatitis, run by Hayatabad Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Musarrat Hussain (00923339212173, drmusarrat9740@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity at 2 hours (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.