Treatment of Acute Pancreatitis With Ketorolac

NCT ID: NCT02885441

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-02-01

Brief Summary

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Patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) Ketorolac or the control group. In patients who cannot tolerate oral medications, ketorolac injection will be used.

Detailed Description

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Patients with acute pancreatitis will be randomly assigned in either study group or control group.

* The study group will receive injection or oral Ketorolac.
* The control group will receive standard medical treatment.

Ketorolac is administrated three times daily by mouth or injection starting from the time of admission for the first three days of hospitalization (72 hours).

Hs-CRP will be measured in admission in addition to standard laboratory tests.It will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. Patients will follow up for organ failure involvement and duration of hospitalization. The study will continue to gather clinical follow up information up to four months.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ketorolac

Ketorolac,10 mg, 3 times daily from time of enrollment until 72 hours from enrollment for up to a maximum of 9 doses, along with the standard medical treatment

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.

Control

The standard medical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ketorolac

Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.

Intervention Type DRUG

Other Intervention Names

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Toradol

Eligibility Criteria

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Inclusion Criteria

1. Predicted Severe Acute Pancreatitis
2. Enrollment within 72 hours of diagnosis
3. Obtaining informed consent
4. Age \>18 years

Exclusion Criteria

1. Heart disease, Hypertension
2. Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding
3. Lactating women
4. Pregnancy
5. Advanced renal disease
6. Hypersensitivity to ketorolac, aspirin, other NSAIDs
7. Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline
8. Active or history of peptic ulcer disease
9. Recent or history of GI bleeding or perforation
10. Inflammatory bowel disease
11. Severe hepatic impairment or active hepatic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ilam University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Vahdat Shariatpanahi

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaahin Shahbazi, MD

Role: STUDY_CHAIR

Head of Faculty of Medicine

Locations

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Ilam University of Medical Scienvc

Īlām, , Iran

Site Status

Countries

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Iran

Other Identifiers

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22/52/1663

Identifier Type: -

Identifier Source: org_study_id

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