Pre-Emptive Analgesia in Dental Implant Surgery

• Status: Withdrawn
• Trial end date: 2017-11-06
• Target enrollment: 0
• Participant gender: All

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 rating scale and the information related to consumption of post-operative medications.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nicholas Salava; Satheesh Elangovan
• Treatments: Anesthetics; Anesthetics, Local; Anti-Inflammatory Agents; Epinephrine; Epinephryl borate; Ibuprofen; Racepinephrine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.