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Morphine in Acute Abdominal Pain

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Morphine
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Abdominal Pain focused on measuring to evaluate the anal. efficacy of IV morph. vs. place. for elderly presenting to the ED with UAP and determine if it has an impact on diag. accu. and phy. exam

Eligibility Criteria

65 Years - undefined (Older Adult)All Sexes

Inclusion Criteria:

  • Elderly (65 years or older) patients with non-traumatic UAP of less than 48 hours' duration were included in the study. Participants were required to have a UAP and report either "mild" or greater pain intensity on a four-point verbal rating scale (VRS) or at least 20 mm on a 100 mm visual analogue scale (VAS).

Exclusion Criteria:

  • Exclusion criteria included known allergy or contraindication to morphine, or any opioid analgesic
  • Hemodynamic instability (systolic blood pressure less than 100 mm-Hg)
  • Use of any analgesic within 6 hours before ED presentation
  • Patients refused to participate to the study
  • Incooperated to the VAS
  • Isolated flank pain or previous study enrollment
  • Patients with known renal, pulmonary, cardiac or hepatic failure were also excluded.

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Morphine

Arm Description

Outcomes

Primary Outcome Measures

Our primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2010
Last Updated
April 27, 2010
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT01112540
Brief Title
Morphine in Acute Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Akdeniz University

4. Oversight

5. Study Description

Brief Summary
The investigators primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group. After follow up information was obtained and patients data were recorded on the SPSS data chart, two blinded coauthors (general surgeon and emergency physician) determined the clinically important diagnostic accuracy and change in physical examination. They firstly defined clinically important diagnostic errors, as any disagreement between the preliminary and final diagnosis that might be expected to have adverse effect on the patient's general status. If coauthors decided an instance of diagnostic error as clinically important, this was coded "diagnostic discordance" for statistical analysis. While the preliminary diagnosis was determined as accurate or not different from the final diagnosis, this was coded "diagnostic accuracy" for statistical analysis. Secondary outcome measures included the need for rescue drugs at 30 minutes, the presence of at least one adverse event, demographic features and final diagnosis of the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
to evaluate the anal. efficacy of IV morph. vs. place. for elderly presenting to the ED with UAP and determine if it has an impact on diag. accu. and phy. exam

7. Study Design

Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Title
Morphine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
0.1 mg/kg Intravenous bolus
Primary Outcome Measure Information:
Title
Our primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria: Elderly (65 years or older) patients with non-traumatic UAP of less than 48 hours' duration were included in the study. Participants were required to have a UAP and report either "mild" or greater pain intensity on a four-point verbal rating scale (VRS) or at least 20 mm on a 100 mm visual analogue scale (VAS). Exclusion Criteria: Exclusion criteria included known allergy or contraindication to morphine, or any opioid analgesic Hemodynamic instability (systolic blood pressure less than 100 mm-Hg) Use of any analgesic within 6 hours before ED presentation Patients refused to participate to the study Incooperated to the VAS Isolated flank pain or previous study enrollment Patients with known renal, pulmonary, cardiac or hepatic failure were also excluded.
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07059
Country
Turkey

12. IPD Sharing Statement

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Morphine in Acute Abdominal Pain

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