Morphine in Acute Abdominal Pain

NCT01112540 | Completed Phase 4

• 1 other identifier: RCT_AE_02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Drug: Morphine

Morphine

EXPERIMENTAL

Drug: Morphine

Interventions

Morphine DRUG

0.1 mg/kg Intravenous bolus

Morphine; Placebo Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Last Updated: April 28, 2010

Record last verified: 2010-04

Locations

TU (1)