RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCE, KARNATAKA

BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR dISSERTATION

1. / Name of the candidate and address / Dr.ANAND
S/o RAMSHETTY.M.
#No.280; SANTHOSHI NILAYA, MAHAVEER NaGaR, NEAR OVERBRIDGE, OLD JEWARGI ROAD,
GULBARGA-585 103.
(KARNATAKA)
Temporary Address / POST GRADUATE STUDENT
DEPT OF ORAL AND MAXILLLOFACIAL SURGERY,
AL-BADAR RURAL DENTALCOLLEGE,
GULBARGA-585 102
(KARNATAKA)
2. / Name of the Institution / AL-BADAR RURAL DENTALCOLLEGE,
GULBARGA-585 102
(KARNATAKA)
3. / Course of the Study and Subject / MASTER OF DENTAL SURGERY (M.D.S)
DEPT OF ORAL AND MAXILLLOFACIAL SURGERY
4. / Date of Admission to course / 23-06-2008
5. / Title of the Topic / “INTRAMUSCULAR ADMINISTRATION OF KETOROLAC VERSUS TRAMADOL POST-OPERATIVELY IN MINOR ORAL SURGERY-A COMPARATIVE STUDY.”
6. / Brief Resume of the Intended work
6.1 / Need for the Study
Minor oral surgeries are the procedures frequently carried out on an out patient day care basis. However pain after these procedures is common and frequently severe and analgesia is necessarily a balance between achieving adequate pain relief, while causing minimum side effects with early discharge.
It’s a very difficult task for the dentists to manage pain after minor oral surgical procedures. Several studies in India as well as foreign countries have demonstrated the efficacy of opiods, andnon steroidal anti-inflammatory drugs (NSAID’S) for the management of post operative pain.
In this study I would like to compare intramuscular ketorolac 30 mg(periphery acting NSAID’S) with intramuscular tramadol 50 mg (centrally acting opiod) which are readily available and cost effective too, for the management of post operative pain relief, duration of analgesia, adverse effects, efficacy after minor oral surgeries.
6.2 / Review of literature
This study in the year 1995 for 60 patients undergoing maxillofacial surgeries and divided them into two groups of 30 patients each. The first group received ketotolac 0.4 mg kg-1 intravenously and the second group received diclofenac 1.0 mg kg-1 intravenously after general anesthesia induction. In this study they compared duration of analgesia, efficacy in the management of pain control, rescue analgesic medication and adverse effects. They concluded that two patients in the ketorolac and three patients in the diclofenac group did not need oxycodone during the study period. Parenteral ketorolac (0.4 mg kg-1 four times in 24 hours) and diclofenac (1.0 mg kg-1 twice in 24 hours) similar but insufficient alone, for analgesia after maxillofacial surgery1.
This study in the year 1998, for 40 patients undergoing surgical removal of at least 2 third molar teeth under general anesthesia. Patients were allocated randomly to one of two groups, group B (n=20) received bupivacaine upto 2 mg kg-1, infiltrated around the inferior alveolar nerves bilaterally, and group K (n=20) received ketorolac 10mg intravenously at the start of surgery, excluding the systematic diseases and patients below 18 yearsof age. In this study compared duration of analgesia, efficacy in the management of pain control, safety, Tolerability, and Adverse effects post operatively. They concluded that the use of 0.5% bupivacaine infiltration was no more effective than a single dose of 10 mg injection of ketorolac while giving rise to a higher rate of minor air way complications and lower patient acceptability and this study also suggests that ketorolac was a better tolerated, equally efficacious agent for sole use2.
This study in the year 1998 for 34 patients were randomly assigned to one of four groups i.e. group I control saline, group II 30mg ketorolac, group III 8mg dexamethasone and group IV 30mg ketorolac + 8mg dexamethasone, under going surgical extraction of all the four third molars under intravenous sedation. The age of the patients ranged from 18 to 35 years included in this study, patients with pain pre operatively on the day procedure, highly anxious patients were excluded from this study. They concluded that post operative analgesia following third molar surgery in the first ten hour was enhanced with preoperative administration of ketorolac. The addition of dexamethasone use to the pre operative regimen did not improve on the analgesic effect provided by ketorolac alone3.
This study in the year 1999 for 23 patients, who required the elective surgical removal of two or four bilaterally symmetrical, impacted third molars were included in this study. The age of the patients ranged from18 to 41 years & patients with a history of cardiovascular disease, Thyrotoxicosis, immunosuppression, diabetes mellitus, or liver disease were excluded from the study. In this study they compared the efficacy & post operative pain with both local anesthetics. They concluded that bupivacaine is significantly better than lidocaine for post operative pain control after minor oral surgical procedures4.
This study in the year 2004 for 64 patients undergoing elective third molar surgery were randomly assigned into one of the two groups (32 in each group), group I received tramadol 50 mg, and group II received ketorolac 30 mg intravenously pre operatively before the surgery after a standard intravenous sedation undergoing surgical extraction of third molar teeth. In this study they compared duration of analgesia, pain intensity, and median time to rescue analgesic and better global assessment. They concluded that pre operative intravenous ketorolac 30 mg, is more effective than tramadol 50 mg for preventing post operative dental pain5.
This study in the year 2005 for 72 patients, undergoing elective third molar surgery, divided in two groups, i.e. oral group & intravenous group. The intravenous group received an oral placebo capsule followed by intravenous tramadol 50 mg pre operatively. In both the groups, a standard intravenous sedation technique was administered and the impacted third molar was removed under local anesthesia. In this study they compared duration of analgesia, pain intensity, and time to rescue analgesic. They concluded that pre operative intravenous tramadol is superior to oral tramadol for preventing post operative pain following third molar surgery6.
6.3 / Objective of the Study
  • To compare onset of analgesia post operatively
  • To compare duration of analgesia post operatively
  • To compare sum of pain intensity differences calculated from the hourly scores for 12 hours post operatively.
  • To compare the adverse effects
  • To compare Efficacy of Analgesics post operatively

7 / Materials and Methods
7.1 / Source of data
Patients undergoing minor oral surgeries reporting to
  1. O.P.D, oral and maxillofacial surgery, Al-badarRuralDentalCollege, Gulbarga.
  2. Selected patients reporting to DentalOPDGovernmentHospital, Gulbarga
  3. Selected surveyed patients reporting to the primary health centre, Gulbarga
Criteria for selection of subjects
Subjects involved in this study are those under going minor oral surgeries.
7.2 / Method of collection of data including sampling procedure:
This study will be conducted in Al-BadarRuralDentalCollege and Hospital with a sample size of 40 cases divided into two groups of 20 cases each. Ketorolac 30mg will be administered intramuscularly in the first group post operatively and tramadol 50mg in the second group.
Inclusion criteria
  • Patients with minor oral surgeries.
  • Patients with age group of 16 to 40 years without any systemic disease or immune deficiency.
Exclusion criteria
  • Patients with systemic disease & immune deficiency.
  • Patients above 40 year of age.
  • Patients with pain pre operatively on the day of the procedure, highly anxious patients were excluded from this study.
Duration of the Study
A follow-up study of Twelve hours i.e. every hour up to 12 hours post operatively.
7.3 / Does the study need any investigation or interactions to be conducted on patients or animals?
Yes
7.4 / Has the ethical clearance been obtained from your institution (in case of 7.3)?
Yes
8. / List of References
  1. Pekka Tarkkila, Marjatta Tauominen, Rosenberg H. Intravenous ketorolac versus diclofenac for analgesia after maxillofacial surgery. Can J Anaesth 1996; 43(3): pp.216-220.
  2. Mellor D.J, Mellor A.H and McAteer E.M. Local anestheticinfiltration for surgical exodontia of third molar teeth: a double-blindstudy comparing bupivacaine infiltration with i.v. ketorolac. British Journal of Anesthesia 1998;81:pp.511-514.
  3. Timothy Claseman S, William Foley L, Richard Davis D. A clinical evaluation of the analgesic Efficacy of preoperative administration of ketorolac and dexamethasone following surgical removal of third molars. Anesth Prog. 1998; 45:pp.110-116.
  4. Gary Bouloux F, Arumugam Punnia-Moorthy. Bupivacaine versus Lidocaine for Third Molar Surgery: A Double-Blind, Randomized, Crossover Study. J Oral Maxillofac Surg 1999; 57:pp.510-514.
  5. OngKS, Tan JML. Preoperative intravenous tramadol versus ketorolac for preventing postoperative pain after third molar surgery. Int.J. Oral Maxillofac. Surg. 2004;33:274-278.
  6. Cliff OngKS, Philip Lirk, Juliana Tan MH. The analgesic Efficacy of Intravenous Versus Oral Tramadol for Preventing Postoperative Pain after Third Molar Surgery. J Oral Maxillofac Surg. 2005: 63: 8: pp.1162-1168.

9. / Signature of Candidate
10. / Remarks of Guide / This study intramuscular ketorolac versus tramadol to control post operative pain in minor oral surgery is taken up due to ease of availability and administration both these drugs have advantages / disadvantages which will be concluded at the end of our research work
11. / Name and Designation of the Guide (In block letters)
11.1 / Guide / Dr. paul. V. JOSEPH
mds
Associate Professor
Department of Oral and Maxillofacial Surgery
Al – Badar Rural DentalCollege & Hospital, Gulbarga
11.2 / Signature
11.3 / Co-guide
11.4 / Signature
11.5 / Head of the Department / Dr. Syed Ahmed mohiuddin
MDS
Professor & Head
Department of Oral and Maxillofacial Surgery
Al – Badar Rural DentalCollege & Hospital, Gulbarga
11.6 / Signature
12. / 12.1 / Remarks of Chairman and Principal / The study which is taken up at our centre will be beneficial to patients who are undergoing minor oral surgery. Although, the ketorolac (nsaid’S) established superiority over other drugs like diclofenac, bupivacaine, paracetamol and ibuprofen. There are very few studies which compares tramadol (Opiod) and ketorolac (nsaid’s) alone with I.M injection post operatively as a single dose without any combinations.
12. 2 / Signature