Status:
WITHDRAWN
Pre-Emptive Analgesia in Dental Implant Surgery
Lead Sponsor:
Satheesh Elangovan
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-64 years
Phase:
EARLY_PHASE1
Brief Summary
To determine the clinical effectiveness of combined use of pre-emptive analgesia and long acting anesthesia for pain suppression following dental implant surgery as measured by a validated numerical r...
Detailed Description
Dental practitioners often prescribe opioids for the relief of moderate - severe acute post-operative pain.1 There is evidence that alternative approaches, such as the use of long acting local anesthe...
Eligibility Criteria
Inclusion
- Adult patients 18 years of age and under 65 years of age
- ASA Type I \& II
- Single tooth edentulous site requiring dental implant placement without any additional bone or soft tissue augmentation at the time of implant placement
- Patients not requiring use of any form of sedation for dental implant surgery (nitrous, oral or IV sedation)
Exclusion
- Hypersensitivity to NSAIDs, salicylates, or microcrystalline cellulose NF (Avicel PH 105)
- Liver disease
- Renal disease
- Hypertension and taking angiotensin-converting-enzyme inhibitors and/or diuretics
- Significant respiratory conditions including acute or severe asthma.
- Cardiovascular disease that will prevent the patient from going through the surgical procedure or consuming the required medications: cardiac disease, cardiomyopathy, cardiac arrhythmias, coronary heart disease, acute MI, angina, history of MI, coronary artery bypass grafting (CABG), Aspirin intake, peripheral vascular disease, cerebral vascular disease (stroke, TIA)
- Gastrointestinal disease including irritable bowel disease and gastric ulcers
- Hematological diseases (coagulopathy, hemophilia or thrombocytopenia)
- Pregnancy/lactation at the time of surgery
- Heavy smoking (\>10 cigarettes per day)
- Diabetes
- Allergies or intolerance to ibuprofen, opioids, and local anesthetic (lidocaine and bupivacaine)
- History of recreational drug abuse
- History of heavy alcohol use. Substance Abuse and Mental Health Services Administration (SAMSHA)30 defines heavy alcohol use as binge drinking on 5 or more days in the past month. SAMSHA defines binge drinking as 5 or more alcoholic drinks for males or 4 or more alcoholic drinks for females on the same occasion (i.e., at the same time or within a couple of hours of each other) on at least 1 day in the past month.
- Patients currently taking prescription pain medications or have taken over-the-counter pain medications within 4 days of surgery.
- Patients with drug-drug or drug-disease state interactions
- Other significant medical conditions (not reported above) that are likely to prevent the patient from going through the surgical procedure or consuming the required medications.
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03243032
Start Date
October 6 2017
End Date
November 6 2017
Last Update
October 12 2018
Active Locations (1)
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1
Univerity of Iowa College of Dentsitry Dental Clinics
Iowa City, Iowa, United States, 52242