Investigation of Apotel, dexamethasone and sublingual buprenorphine with Apotel, dexamethasone and fentanyl in pain control after surgery
Phase 3
- Conditions
- Condition 1: pain. Condition 2: nausea and vomiting. Condition 3: anxiety.Pain, unspecifiedNausea and vomitingOther anxiety disorders
- Registration Number
- IRCT20220727055571N1
- Lead Sponsor
- Ardabil University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Age 15-70 years
patients with lower limb fracture
Exclusion Criteria
History of drug abuse
alcohol consumption
recent use of tranquilizers, stimulants and antipsychotics
antihypertensive drugs
calcium channel blockers
and history of neuromuscular diseases
thyroid disorders
history of any type of kidney and heart disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain. Timepoint: 4at 2, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.
- Secondary Outcome Measures
Name Time Method ausea and vomiting. Timepoint: at 2, 6, 12 and 24 hours after the operation. Method of measurement: Based on a qualitative review by the following method:1- No nausea and vomiting 2- Nausea 3- Nausea and vomiting one to two times 4- Nausea and vomiting more than 2 times.;Anxiety and restlessness. Timepoint: at 2, 6, 12 and 24 hours after the operation. Method of measurement: According to Ramsey scale (0 to 5): 0 (restless), 1 (calm and alert), 2 (sleepy), 3 (confused but responding to verbal commands), 4 (no response to verbal commands), 5 (absence) response to provocations)).