UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037790 |
|---|---|
| Receipt number | R000043095 |
| Scientific Title | Intravenous Paracetamol vs Tramadol for pain management in patients with Acute Pancreatitis |
| Date of disclosure of the study information | 2019/08/24 |
| Last modified on | 2020/08/24 13:28:15 |
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Basic information
Public title
Intravenous Paracetamol vs Tramadol for pain management in patients with
Acute Pancreatitis
Acronym
PCM vs Tramadol in Pain Management in AP
Scientific Title
Intravenous Paracetamol vs Tramadol for pain management in patients with
Acute Pancreatitis
Scientific Title:Acronym
PCM vs Tramadol in Pain Management in AP
Region
| Asia(except Japan) |
Condition
Condition
Pain Management in Acute Pancreatitis
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of Intravenous Paracetamol for abdominal pain in acute pancreatitis compared with Tramadol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the efficacy of Paracetamol vs Tramadol in pain management of Acute Pancreatitis.
Key secondary outcomes
1)To determine number of patients with drug related adverse events in paracetamol vs tramadol arm
2)To determine causes of acute pancreatitis
3)To analyze the incidence of severity of acute pancreatitis as per the revised Atlanta Classification
4)To determine impact of two drugs on duration of hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be given IV Paracetamol1gm in 100 ml NS over 4-5 min infusion thrice daily and pain will be assessed by using VAS scores after 24 hours.
Interventions/Control_2
Patients will be given IV Tramadol 50 mg in 100 ml NS over 4-5 min infusion thrice daily and Pain will be assessed by using VAS scores after 24 hours.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Adult patients (>18 years age)
2)Diagnosis of Acute Pancreatitis with abdominal pain
Key exclusion criteria
1)Severe hepatic impairment
2)Severe renal impairment ( CrCl < 30ml/min)
3)Ongoing treatment with NSAIDs (within 24 h)
4)History of allergy to paracetamol, and/or tramadol
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Roshan |
| Middle name | |
| Last name | Shrestha |
Organization
National Academy of Medical Sciences, Bir Hospital
Division name
Gastroenterology Unit
Zip code
44600
Address
Mahabouddha, Kathmandu
TEL
9779851136352
roshan_sth@hotmail.com
Public contact
Name of contact person
| 1st name | Roshan |
| Middle name | |
| Last name | Shrestha |
Organization
National Academy of Medical Sciences, Bir Hospital
Division name
Gastroenterology Unit
Zip code
44600
Address
Mahabouddha, Kathmandu
TEL
9779851136352
Homepage URL
http://www.nams.org.np
roshan_sth@hotmail.com
Sponsor or person
Institute
National Academy of Medical Sciences, Bir Hospital
Institute
Department
Personal name
Funding Source
Organization
National Academy of Medical Sciences, Bir Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Nepalese
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Academy of Medical Sciences, Bir Hospital
Address
Mahabouddha ,Kathamandu, Nepal
Tel
+977-1-4230710
admin@nams.org.np
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
National Academy of Health Sciences, Bir Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
78
Results
In this study, 80 patients were enrolled and included in the final analysis. The study subjects had a mean age of 39.33 +/- 13.3 years and 62(77.5%) of them were male. Alcohol was the etiology for pancreatitis in 67.5% (n=54) of patients. Mean VAS scores at baseline and 24 hours were similar in the two groups. Similarly, the change of scores from the baseline to the 24 hours did not differ between the groups. Comparison of pain improvements failed to reveal any differences between groups
Results date posted
| 2020 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean Age
Gender
Clinical symptoms and signs
Nausea
Vomiting
Abdominal Tenderness
Guarding
Muscle rigidity
Etiology for pancreatitis
Alcohol
Biliary
Others
Severity of AP as per revised Atlanta Classification
Acute
Moderately severe
Severe
Participant flow
Flow Diagram of the participants in the study
90 patients were assessed for eligibility
10 Excluded
2 declined to participate
8 had various reasons
80 randomized
40 allocated to paracetamol 40 allocated to tramadol
40 included in analysis 40 included in analysis
Adverse events
Variables Paracetamol
n(%) Tramadol
n(%)
Allergic reaction (urticaria or itching) 0 (0%) 0 (0%)
Giddiness 0 (0%) 0 (0%)
Nausea and vomiting 0 (0%) 1 (2.5%)
Sedation 0 (0%) 0 (0%)
Others 0 (0%) 0 (0%)
Outcome measures
Variable Paracetamol Group Tramadol Group P value
Baseline VAS (mean) 7.6 7.93
24 Hours VAS (mean) 0.98 1.43
Change from Baseline (mean) 6.63 6.5 0.691
VAS: visual analogue scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 24 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043095
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