Morphine in Acute Abdominal Pain

This study has been completed.
Sponsor:
Information provided by:
Akdeniz University
ClinicalTrials.gov Identifier:
NCT01112540
First received: April 26, 2010
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Abdominal Pain
Drug: Morphine
Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Akdeniz University:

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

Arms Assigned Interventions
Placebo Comparator: Placebo Group Drug: Morphine
0.1 mg/kg Intravenous bolus
Experimental: Morphine Drug: Morphine
0.1 mg/kg Intravenous bolus

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01112540

Locations
Turkey
Akdeniz University
Antalya, Turkey, 07059
Sponsors and Collaborators
Akdeniz University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01112540     History of Changes
Other Study ID Numbers: RCT_AE_02
Study First Received: April 26, 2010
Last Updated: April 27, 2010
Health Authority: Turkey: Ethics Committee
Turkey: Ministry of Health

Keywords provided by Akdeniz University:
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

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 29, 2014