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Comparison of the analgesic effect of paracetamol and morphine with morphine alone in patients with abdominal pain suspected biliary origi

Phase 2
Conditions
Abdominal pains with biliary origin.
Pain localized to upper abdomen
Registration Number
IRCT201206099984N1
Lead Sponsor
Vice chancellor for research, Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
90
Inclusion Criteria

Aged = 18 and =65 years; Abdominal pain that clinical or Para clinical (evidence of gallbladder or biliary tract stones during the last 12 months) is in favor of biliary origin; NRS = 3. Exclusion criteria: Aged ?18 years and ?65years; Known hypersensitivity to opioids or paracetamol; Unstable vital signs: systolic blood pressure ?90mmHg; Evidence of peritoneal irritation; Pregnancy; Prior to entering the study; Patients with known renal, hepatic or cardiac failure; Patients with transplants (kidney, lung, liver, or heart); Lack of patient consent for participation in the study; Decreased level of consciousness (GCS ?15); Mental retardation; NRS ?3; having received Analgesics during the last 6 hours before presenting to the emergency department; Addiction to opium or methadone use.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The analgesic effect of drugs. Timepoint: Immediately before, 15, 30 minutes after drugs administration. Method of measurement: Pain scores (VAS, NRS).
Secondary Outcome Measures
NameTimeMethod
Requirement to rescue doses of fentanyl. Timepoint: No significant reduction in pain 30 minutes after drug administration (difference between first and last VAS ?3 mm) and ask for pain medication by the patient at any time during the one hour under the observation. Method of measurement: Clinical examination and asking the patient.;Pruritus, Rash. Timepoint: Within one hour after administration of drugs. Method of measurement: Clinical examination and questionnaire.;Dizziness. Timepoint: Within one hour after administration of drugs. Method of measurement: Clinical examination and questionnaire.;Nausea and vomiting. Timepoint: Within one hour after administration of drugs. Method of measurement: Clinical examination and questionnaire.;Hypotension. Timepoint: Within one hour after administration of drugs. Method of measurement: Clinical examination and questionnaire.
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