Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
1 other identifier
interventional
64
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2016
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 14, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedOctober 18, 2016
October 1, 2016
2 months
October 14, 2016
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse drug reactions (questionnaire)
Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis
24 hours
Secondary Outcomes (4)
Postoperative pain (Numeric Pain Rating Scale)
24 hours
systemic blood pressure (mmHg) (physiological parameter)
24 hours
Heart rate (physiological parameter)
24 hours
Oxygen saturation (physiological parameter)
24 hours
Study Arms (2)
Morphine
ACTIVE COMPARATORMultimodal analgesia to morphine
Oxycodone
EXPERIMENTALMultimodal analgesia to oxycodone
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Patients scheduled for abdominal hysterectomy
- Signing for informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Pharmacology
Study Record Dates
First Submitted
October 14, 2016
First Posted
October 18, 2016
Study Start
October 1, 2016
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
October 18, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share