NCT02936934

Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Hospital Civil de Guadalajara · Academic / Other
• Sex: Female
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

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: 1. A clinical history of patients candidates to participate in the study will be developed. 2. 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) • the patient to group A or B (randomization) is assigned, masking infusions and allocation will be conducted by an outside person who will test an additional record the names of the patients and the drug administered. A bolus of oxycodone or morphine 10% calculated dose for intravenous infusion 0.075mg intravenous palonosetron prophylaxis of emesis Detection and assessment of severity of adverse drug reactions will be conducted by an interview that will be at 0,1,2,6,12 and 24 hours after the onset of analgesia. Instrument designed for the detection of RAM will be used and classify its severity according to common terminology criteria for adverse events (CTCAE). Futhermore, measuring systemic blood pressure, heart rate, oxygen saturation will be performed through the use of Nihon Kohden monitor (model BSN-2301K). Pain assessment will be made by the numerical scale (NRS). The researcher responsible for the detection and assessment of adverse reactions to opioids and others determinations, remain mowed.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Morphine	Interventions pre-specified to be administered to participants: Abdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery Intravenous infusion: 200μg / kg of morphine + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration:24hours
DRUG	Oxycodone	Interventions pre-specified to be administered to participants: Abdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery Intravenous infusion: 150μg / kg of oxycodone + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration: 24hours.

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2016-10-18
• Last updated: 2016-10-18