Morphine in Acute Abdominal Pain

Abdominal Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112540
• Other study ID #: RCT_AE_02
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2010
• Last updated: April 27, 2010

Study information

• Verified date: April 2010
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Drug:
• Morphine
0.1 mg/kg Intravenous bolus

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group.