Rajiv Ghandhi University of Health Sciences

RAJIV GHANDHI UNIVERSITY OF HEALTH SCIENCES.

KARNATAKA, BANGALORE.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION. 1. Name of the candidate and address. Dr. PRATHIBHA.G (in block letters ) NO 181, 3rd MAIN, 11th CROSS H.I.G COLONY, RMV 2nd STAGE BANGALORE-94

2. Name of the institution. M.S. Ramaiah Dental College and Hospital, Bangalore- 54.

3. Course of the study and subject. Master of Dental Surgery in Oral and Maxillofacial Surgery.

4. Date of admission to course. 2/05/2007.

5. Title of the topic. “COMPARATIVE STUDY OF INTRAVENOUS TRAMADOL VERSUS KETOROLAC FOR PREVENTING POST OPERATIVE PAIN AFTER THIRD MOLAR SURGERY”. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY

Surgical extractions of third molars are considered as one of the routine aspects of oral- maxillofacial surgery. Patients complain of pain, swelling in response to the third molar surgical extraction as the factors affecting their daily life. Third molar surgical pain is highly predictable; moderate to severe pain will develop during the first 12 hours after surgery and peaks at about 6- 8 hours when a conventional local anaesthetic is used. Because this pain is so predictable it is suggested that prevention of third molar surgical pain is a better management strategy than treating pain once it as occurred. It embodies the idea that the pain perceived after a tissue injury may be modified or preempted by an analgesic administered before precipitating the unpleasant stimulus. Various modalities including administration of drugs such as diclofenac, aceclofenac, paracetamol etc; are used either parentally or orally to reduce the post operative, in which Tramadol and Ketorolac are among them. So this study aims to compare the analgesic efficacy of single-dose preoperative intravenous Tramadol versus Intravenous Ketorolac for preventing pain after third molar surgery. 6.2 REVIEW OF LITERATURE

Ketorolac is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs. It possesses analgesic, anti-inflammatory and antipyretic activity. The primary action of ketorolac appears to be inhibition of the cyclooxygenase enzyme that metabolizes arachidonic acid to endoperoxide intermediates and prostaglandins that promote.pain.1 Tramadol is a centrally acting synthetic analgesic compound that is structurally related to codeine and morphine. It has a dual mechanism of action that involves weak affinity for opiod receptors and also inhibition of reuptake of serotonin and norepinephrine at synapses in the descending inhibitory pain pathway. 2 Tramadol does not affect the prostaglandin synthesis; it does not have antipyretic or anti- inflammatory effects. Oral tramadol has been found to be effective for post operative dental pain control. Single dose of tramadol is more effective. Dose related adverse events with tramadol treatment included vomiting, nausea, dizziness and somnolence. 2, 3 Preemptive analgesia in its original form comprised of two postulates: Firstly, an analgesic intervention started before nociception would be more effective than the same intervention commenced afterwards; and Secondly, this advantageous effect would outlast the pharmacological duration of action of the analgesic concerned. The aim of such treatment is to prevent the central nervous system from reaching a hyperexcitable state known as central sensitization or the wind-up phenomenon, in which it responses excessively to afferent inputs. The clinical implication would be more effective pain management, thereby reducing postoperative pain and analgesic requirement. 4 Ketorolac is the only nonselective NSAID currently available for injectable use, but it is associated with typical NSAID-related side effects, including GI bleeding, ulceration, and altered platelet function. 5

6.3 OBJECTIVES OF THE STUDY o The aim of this study is to compare the analgesic efficacy of single-dose of preoperative Intravenous tramadol versus Intravenous Ketorolac for preventing pain after third molar surgery. o To assess the difference in postoperative pain in both the groups.

7. MATERIALS AND METHODS 7.1 SOURCE OF DATA

This study includes 40 patients reporting to the Department of Oral and Maxillofacial Surgery with Impacted third molar in a period of 18 months.

STUDY DESIGN: Randomized Interventional Clinical Trial.

STATISTICAL TEST APPLIED: Demographic data, duration of operation, Amount of local anesthetic used, are evaluated with unpaired student‘t’ test. The difference in pain scores and total postoperative analgesic consumption are analyzed using Mann-Whitney U test. The comparison of time to taking of rescue analgesic is based upon log rank test. Patients taking rescue analgesia are analyzed with Fisher`s exact test. Global assessment is assessed by Chi Square test.

INCLUSION CRITERIA 1. Patients indicated for surgical removal of impacted mandibular third molar. 2. Patients with no previous history of infection or pain in the week before surgery. 3. Patients’ age groups between 18-35yrs are included in the study.

EXCLUSION CRITERIA

1. Patients with history of hypersensitivity to tramadol and ketorolac. 2. Patients with a recent history of pain due to infection at the proposed surgical site. 3. Medically compromised patients.

7.2 DOES YOUR STUDY REQUIRE ANY INVESTIGATION TO BE CONDUCTED? 1. Routine blood and urine investigations. 2. IOPA Radiographs and OPG

7.3 METHOD OF COLLECTION OF DATA It is a comparative study which includes forty patients under going mandibular Third molar surgery. They are randomly assigned into one of two Groups: GROUP 1: This group of patients will be receiving tramadol 50 mg intravenous Preoperatively GROUP 2: This group of patients will be receiving ketorolac 30 mg intravenous Preoperatively. Patients are managed as follows:  Written consent.  Presurgical Clinical and radiographic examination.  Antibiotic prophylaxis with amoxicillin (1 gm).  Mouth rinse with 0.2% chlorhexidine.  Inferior nerve block using 2% lignocaine with 1:200000 adrenaline.  Surgical procedure: Impacted mandibular third molar are removed using Standard surgical technique. The difference in postoperative pain will be assessed by four primary end points:  Pain intensity as measured by 10-mm VAS hourly for 12 hours.  Median time to rescue analgesic.  Total analgesic consumed during the recovery period (5 days).  Global assessment: Patients are asked to provide an overall efficacy of the surgery with regard to pain on a five- catagorical scale at the end of the trial. 0=poor, 1=fair, 2=good, 3=very good, 4=excellent

8. LIST OF REFERENCES.

1. K.S.Ong, J.M.L.Tan. Preoperative intravenous tramadol versus ketorolac for preventing postoperative pain after third molar surgery. Int J Oral Maxillofac Surg 2004; 33 274-278.

2. Cliff K.S.Ong et al. The analgesic Efficacy of Intravenous versus Oral Tramadol for preventing postoperative pain after third molar surgery.J Oral Maxillofac Surg 2005; 63: 1162-1168.

3. James R. Firke Jr et al. A double-blind placebo-controlled comparison of tramadol/acetoaminophen and tramadol in patients with postoperative dental pain. J pain 2004; 109: 250-257.

4. K.S.Ong et al. Preoperative ketorolac has a preemptive effect for postoperative third molar surgical pain. Int J. Oral Maxillofac Surg 2004; 33: 771-776

5. Donald R. Mehlisch et al. Single dose of parecoxib sodium intravenously are as effective as ketorolac in reducing pain after oral surgery. J Oral Maxillofac Surg 2003; 61: 1030-1037.

8.1 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR . INSTITUTION IN CASE OF ABOVE?

YES. PROFORMA

Name: Date: O.P.NO: Age: Sex: Address:

Occupation: Chief Complaint:

H/O Pericoronitis/Abscess:

Any Treatment Received: Y/N

If Yes Please Specify:

Dental History:

Medical History:

Drug Allergy:

Clinical Examination: Extraoral: Facial Symmetry: Mouth Opening:

Intraoral: IMPACTED TOOTH: Surrounding Soft Tissue: Inflamed/Normal Ulcer: Present/Absent Fibrosed: Y/N. Completely Covered by Soft Tissue or Partially exposed.

PERICORONITIS: Acute Infection if any: Swelling: Y/N Discharge: Y/N Pain/Difficulty in chewing: No of episodes: UPPER TOOTH: Present/Absent: Impinging on the soft tissue: Y/N. Position: Normal. Buccal. Supra Erupted.

Condition of Second Molar: Any Caries: Periodontal Involvement: RCT: Y/N. Tongue: Macro/Micro/Normal.

Investigations: IOPA:

Radiographic and Clinical Correlation:

Tooth Impaction: Y/N.

Diagnosis:

Classification:

WAR Lines:

WHARF Assessment:

Surgical Method:

Block:

Incision:

Procedure: Duration: Amount of L.A used in ml:

Medication:

Follow Up and Complications:

0 1 2 3 4 5 6 7 8 9 10 No pain worst pain VISUAL ANALOG SCALE

No pain Worst pain

NO OF ANALGESIC CONSUMED DURING THE RECOVERY PERIOD (5 DAYS):

MEDIAN TIME TO REMEDICATION: GLOBAL ASSESSMENT: 0 = POOR: 1 = FAIR: 2 = GOOD: 3 = VERY GOOD: 4 = EXCELLENT: