Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 64
- Primary Endpoint
- Adverse drug reactions (questionnaire)
Study Overview
Brief Summary
The objective of this study is compare adverse reactions associated with oxycodone and morphine for the treatment of postoperative pain after abdominal hysterectomy
Detailed Description
A randomized single-blind study, was performed to compare the adverse reactions associated with oxycodone and morphine in patients undergoing abdominal hysterectomy.
process:
- A clinical history of patients candidates to participate in the study will be developed.
- If you meet the selection criteria will be held the invitation to participate in the study, reading the letter under information
Patients who agree to participate in the study will be managet during the surgical procedure:
15 mg mixed blockade with bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg intravenously during surgery metamizol 3) After the surgical procedure (immediate postoperative)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients scheduled for abdominal hysterectomy
- •Signing for informed consent
Exclusion Criteria
- •Patients used with MAO inhibitor drugs (<14 days before surgery)
- •History of substance abuse
- •Hypersensitivity to opioids and others drugs of multimodal analgesia (metamizol and lidocaine)
- •Pretreatment of any opioid (<7/2 lives of the drug in question)
- •Chronic pain of any etiology (> 6 months)
- •Diagnosis of bowel obstruction
- •Renal or hepatic insufficiency
- •Asthma, chronic obstructive pulmonary disease (COPD), and/ or hypothyroidism.
- •Patients requiring general anesthesia for surgical complications
Arms & Interventions
Morphine
Multimodal analgesia to morphine
Intervention: Morphine (Drug)
Oxycodone
Multimodal analgesia to oxycodone
Intervention: Oxycodone (Drug)
Outcomes
Primary Outcomes
Adverse drug reactions (questionnaire)
Time Frame: 24 hours
Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis
Secondary Outcomes
- systemic blood pressure (mmHg) (physiological parameter)(24 hours)
- Postoperative pain (Numeric Pain Rating Scale)(24 hours)
- Heart rate (physiological parameter)(24 hours)
- Oxygen saturation (physiological parameter)(24 hours)
Investigators
VIRGINIA ALEYDA SANCHEZ LOPEZ
MD Pharmacology
Hospital Civil de Guadalajara