Abdominal pains with biliary origin. Pain localized to upper abdomen
Conditions
Interventions
Intervention 1: For the intervention group we infused 1000mg paracetamol in 100 cc normal salin over 15 min and 0.05mg/kg morphine that diluted in 5cc normal salin over 5 mins. Intervention 2: In the
Treatment - Drugs
Placebo
For the intervention group we infused 1000mg paracetamol in 100 cc normal salin over 15 min and 0.05mg/kg morphine that diluted in 5cc normal salin over 5 mins.
In the control group we infused 0.1mg/kg morphine diluted into 5 ml normal saline within 5 mins.
In the control group we infused 100 cc normal saline within 15 mins.
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The analgesic effect of drugs. Timepoint: Immediately before, 15, 30 minutes after drugs administration. Method of measurement: Pain scores (VAS, NRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBabaei Rasoul
Shariati Hospital
Outcome results
None listed