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Morphine in Acute Abdominal Pain

NCT ID: NCT01112540

Last Updated: 2010-04-28

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

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Pain

Keywords

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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

Study Groups

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Placebo Group

Group Type PLACEBO_COMPARATOR

Morphine

Intervention Type DRUG

0.1 mg/kg Intravenous bolus

Morphine

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

0.1 mg/kg Intravenous bolus

Interventions

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Morphine

0.1 mg/kg Intravenous bolus

Intervention Type DRUG

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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RCT_AE_02

Identifier Type: -

Identifier Source: org_study_id