RAJIV GANDHI UNIVERSITY OF HEALTH SCEINCES, KARNATAKA, BANGALORE.
ANNEXURE– II
PFOFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the candidate and address (in block letters) / Dr. SEHAM SYEDA
POST GRADUATE STUDENT
DEPARTMENT OF ANAESTHESIOLOGY
KIMS
HUBLI-580022.
2. / Name of the Institution / KARNATAKA INSTITUTE OF MEDICAL SCIENCES,
HUBLI-580022.
3. / Course of Study & Subject / M.D. IN ANAESTHESIOLOGY.
4. / Date of admission to course / 15-06-2012
5. / Title of the topic / “TO EVALUATE THE EFFICACY OF PREOPEREATIVE INTRAVENOUS PARACETAMOL VS INTRAVENOUSTRAMADOL FOR POSTOPERATIVE ANALGESIA IN PEDIATRIC SURGERY UNDER GENERAL ANAESTHESIA”
6. / Brief resumeof the intended work
6.1 Need for the study
Pain serves as a biological function. It signals the presence of damage or disease within the body. Acute pain is a common and suboptimally managed occurrence in perioperative settings1.
Furthermore, postoperative pain is associated with various complications and poor outcomes including longer time to ambulation, longer hospital stay,higher rates of medical complication and decreased patient satisfaction.
Long term complication also can arise from undetected postoperative pain,including worse functional outcomes and a higher prevalence of chronic pain syndrome.
The goal of optimizing the postoperative pain is to relieve patients suffering,earlymobilization,shortened hospital stay, reduced costs and side effects.
Non-steroidal anti-inflammatory drugs(NSAIDS) are effective in reducing postoperative pain with a lower risk of postoperative nausea and vomiting(PONV). However they also introduce the possibility of increased bleeding due to their antiplatelet effects2 and increased incidence of renal failure.
Opioids provide satisfactory analgesia and better emergence in children undergoing surgery but prolonged sedation is one of the reasons for delayed discharge from the hospital after day care surgeries.2
Paracetamol is a non-opioid analgesic that is devoid of above risks.It provides rapid and effective pain relief in perioperative settings. Its efficacy3 and tolerability3 are well established.
Paracetamol has the advantage of being the only non-opioid analgesic available in oral, rectal and intravenous formulation3.
Intravenous paracetamol is a soluble diethyl glycidyl ester of paracetomol. Intravenous route is especially advantageous in postsurgical situations when oral(e.g. infections with severe fever or vomiting) or rectal(e.g. high variability in uptake and bioavailability)3 routes are not suitable or effective.
IV paracetamol achieves target plasma concentration more rapidly and reduced variability compared to rectal and oral formulations.3
Paracetamol acts on both components of pain pathways central and peripheral. Its analgesic action is assumed to be mediated by serotonergic mechanism and the antipyretic action via inhibition of COX-3 in hypothalamus3.
Tramadol is a synthetic opioid of aminocytohexanolgroup .
It acts as a weak μ opioid receptor agonist. It is available both in injectable( intravenous andintramuscular route) and oral formulations.
Intravenous tramadol is a potent analgesic which is a synthetic 4-phenyl piperidine analogue of codeine. It is a centrally acting opioid weak inhibitor of norepinephrine and serotonin reuptake. It is known to cause nausea and vomiting.4
6.2 Review of literature :
  • A prospective, randomized double blinded study conducted among 64 patientsbetween age group of 6-16 yearsdone to compare the efficacy IV paracetamol and IV tramadol for postoperative analgesia showed that IV paracetamol and IV tramadol are associated with similar analgesic properties and early recovery with IV paracetamol to that of IV tramadol after adenotonsillectomy in children.2
  • A prospective, randomized double blinded study conducted among 40 patients between age group of 3-16 years done to compare IV paracetamol and IM meperidine on pain and discharge time after pediatric dental restoration showed that IV paracetamol resulted in slightly higher pain scores but earlier readiness for recovery room discharge5.
  • A prospective , randomized double blinded study done to compare the analgesic effects of IV paracetamol and IM meperidine should that IV paracetamol provided adequate analgesia, less sedation and earlier readiness for recovery room discharge among pediatric patients undergoing tonsillectomy6.
  • A prospective, randomized, double blinded study conducted on 50 children in age group of 2-5 years done to compare duration of analgesia following IV acetaminophen(paracetamol) or rectal acetaminophen after adenotonsillectomy in children showed that rectal route provided longer analgesia when compared to IV route7.
  • A prospective,randomized double blinded study conducted among 28 patients between age group 6months-2years done to compare the pharmacokinetics and analgesic effects of IV propacetamolvs rectal paracetamol in children after major craniofacial surgery showed that IV propacetamol is more effective8.
  • A prospective, randomized double blinded study conducted among 183 patients aged between 1-12years admitted for inguinal hernia under general anaesthesia combined with ilioinguinal block done to compare tolerance and relative analgesic efficacy of IV paracetamol and IV propacetamol (prodrug of paracetamol) during 1st 6hours after inguinal repair showed IV paracetamol similar analgesia but it was better tolerated at the injection site than propacetamol9.
  • A prospective randomized double blinded study conducted among 50 pediatric patients between age group 4-12years to demonstrate the efficacy of preemptive IV paracetamol and IV tramadol for postoperative analgesia in adenotonsillectomy showed no significant difference between two groups10.
  • A prospective, randomized double blinded study conducted on 60 patients in the age group of 10-30 years undergoing tonsillectomy to compare analgesic effects of paracetamol,diclofenac sodium and tramadol showed immediate post tonsiilectomy pain control with tramadol and diclofenac is superior to IVparacetamol11.
6.3 Objective of the study
  • The study of using intravenousparacetamol for postoperative analgesia has the following objectives
  • To evaluate the :
  1. Onset of analgesia
  2. Duration of analgesia
  3. Efficacy in pain relief
  4. Number of patients requiring rescue analgesia
  5. Time to first rescue analgesia
  6. Time and quality of recovery
  7. Adverse effects : like nausea and vomiting,infusion site adverse reactions,pruritis.
  • To compare the above effects with that of intravenous tramadol.

7. / Materials and methods
7.1 Source of data
The present study will be conducted on 64 patients aged between 2-12yrs who are scheduled for various elective surgeries under general anaesthesia in Karnataka Institute of medical sciences, HUBLI.
7.2 Method of collection of data
SAMPLE SIZE:
A total number of 64 patients of ASA grade I and II of age group between 2-12yrs undergoing various elective surgeries under general anaesthesia would be allocated to two groups randomly after taking informed written consent from the parents. A prospective, randomized, double blinded study is planned for a duration of 1 year from Jan 2013 to Dec 2013.
Inclusion criteria
  • Patients with ASA grade I and II
  • Patients aged between 2-12years
Exclusion Criteria
  • Patients belonging to ASA grade III and IV
  • Patients with medical complications like severe anemia, serve hypovolemia, septicemia
  • Patients with abnormal BT, CT or on anticoagulants.
  • Patients with history of hypersensitivity to the study drugs.
METHOD OF STUDY
A prospective randomized, double blinded study would be undertaken, 64patients with moderate to severe pain following various elective surgeries under general anaesthesia would be assigned to two groups, each containing 32 patients.
  • Group ‘P’ - would receive intravenous parcetamol 15mg/kg body weight in 75 ml normal saline over 15minutes infusion.
  • Group ‘T’ – would receive intravenous tramadol 1mg/kg body weight in 75 ml normal saline over 15 minutes infusion.
  • All patients who are in the inclusion criteria will be assessed by a pre anaesthetic evaluation a day before surgery.
  • Children were fasted from solid food for 6 hours before surgery clear liquid were permitted until two hours prior to surgery.
  • In the operating room electrocardiography,non invasive blood pressure and pulse oximetry were connected.
  • Intravenous fluids will be given according to the body weight of the patient and surgical loss.
  • All patients are pre medicated with injection glycopyrrolate0.01mg/kg, injection pentazocine 0.3mg/kg and injection midazolam 0.05mg/kg given intravenously.
  • Induction with injection thiopentone 5mg/kg and succinylcholine 2mg/kg.
  • Endotracheal intubation will be done with appropriate sized tube.
  • Anaesthesia maintained with 60% nitrous oxide in oxygen and controlled ventilation using injection vecuronium 0.08mg/kg i.v.
  • After induction and before surgical incision
  • Group ‘P’- will receive intravenousparacetamol 15mg/kg body weight.
  • Group ‘T’-will receive intravenous tramadol 1mg/kg body weight over 15minutes. The medications will be diluted with normal saline to a total volume of 75ml and infused over 15minutes.
  • Neuromuscular blockade will be reversed with injection neostigmine 0.05mg/kg and glycopyrrolate after adequate respiratory efforts. Patients will be extubated after satisfactory motor recovery.
  • Postoperative pain will be observed for 24 hours based on visual analogue scale >8years and CHEOPS scale <7years.
  • During the first 6 hours, patients with a pain score of >4 on visual analogue score or CHEOPS scale >4 would receive IV meperidine 0.5mg/kg and after 6hours oral paracetamol 20mg/kg body weight every 6hours.
PARAMETERS STUDIED
  • Baseline pulse rate, BP, temperature,spo2.
  • Intraoperatively PR,BP, temperature and spo2 is recorded every 15 minutes till the end of procedure.
  • Postoperatively pain assessed using
CHEOPS SCALE-in patients aged below 7yrs
VISUAL ANALOGUE SCALE(VAS)- above 8yrs of age.
  • Patient is observed for pain relief at 15 mins., 30 mins., 1hr, 2hrs, 4hrs, 6hrs, 8hrs, 12hrs, and 24 hrs using visual analogue scale and CHEOPS accordingly
  • Pain relief at 0, 12 hrs and 24hrs will be evaluated as per pain relief scale. (Poor, good, fair and excellent)
  • Duration of analgesia will be calculated from time zero to resurfacing of the pain.
  • Quality of analgesia (Excellent, good, fair, poor) will also be noted.
  • Number of patients requiring recue analgesia.
  • Time for first rescue analgesia.
  • Any adverse reactions are noted.
Statistical analysis
The statistical analysis is based on
  • t-test and ANOVA test for parametric data
  • chi-square test for non-parametric data
  • Does the study require any investigations or interventions to be conducted on
patients or other humans or animals ? If so, please describe briefly.
No special investigations required.
7.4 Has ethical clearance been obtained from your institution is case of 7.3 ?
Yes
Approval from ethical committee, KIMS,HUBLIhas been taken and informed written consent would be taken from patients.
8. / LIST OF REFERENCES
  1. Warfeild CA, Kahn CH. Acute pain management. Programs in U.S. hospitals and experiences and attitudes among U.S. adults. Anesthesiology.1995;83(5):1090-1094.
  2. Uysal HY, Takmaz SA, Yaman F, Baltaci B, Basar H. The efficacy of intravenousparacetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children. J ClinAnesth. 2011 Feb;23(1):53-7.
  3. Duggan ST, Scott LJ. Intravenous Paracetamol (Acetaminophen).Drugs 2009;69(1):101-113.
  4. Finkel et al. An evaluation of the efficacy and tolerability of oral tramadol hydrochloride tablets for the treatment of post surgical pain in children. AnesthAnalg. 2002 Jun;94(6):1469-73.
  5. Alhashemi JA, Daghistani MF. Effects of intraoperative intravenous acetaminophen vs. intramuscular meperidine on pain and discharge time after paediatric dental restoration. Eur J Anaesthesiol. 2007 Feb;24(2):128-33.
  6. Alhashemi JA, Daghisthani MF. Effects of intraoperativei.v. acetaminophen vsi.m. meperidine on post tonsillectomy pain in children. Br J Anaesth. 2006 Jun;96(6):790-5.
  7. Capici F, Ingelmo PM, Davidson A, et al. Randomized controlled trial of duration of analgesia following intravenous or rectal acetaminophen after adenotonsillectomy in children. Br J Anaesth. 2008 Feb;100(2):251-5.
  8. Pharmacokinetics and analgesic effects of intravenous propacetamolvs rectal paracetamol in children after major craniofacial surgery. PaediatrAnaesth. 2008 Jul;18(7):589-92.
  9. Murat I, Baujard C, Foussat C, et al. Tolerance and analgesic efficacy of a new i.v.Paracetamol solution in children after inguinal hernia repair. PaediartAnaesth. 2005;15(8):663-70.
  10. Turan G, YukselG,Ormanci F. Preemptive Analgesia with Paracetamol and Tramadol in PediatricAdenotonsillectomy. J Anesth Res.2012;3:231.
  11. Alwan AM, Aljibori AS, Shinawa RM. Comparison of post-tonsillectomy drugs( Paracetamol, Diclofenac sodium and Tramadol).Tikrit Journal of Pharmaceutical Sciences.2009;5(2):156-9.

9. / SIGNATURE OF THE CANDIDATE:
10. / REMARKS OF THE GUIDE: / THIS TOPIC IS SELECTED BECAUSE VERY FEW STUDIES ARE CONDUCTED WITH I.V. PARACETAMOL AS ANALGESIC IN PEDIATRIC SURGERIES AND ALSO TO COMPARE ANALGESIC EFFECTS OF I.V. PARACETAMOL WITH I.V. TRAMADOL TO TREAT POSTOPERATIVE PAIN.
11. /

11.1 NAME AND DESIGNATION OF THE GUIDE

/ DR. JYOTHI. B. M.D.
ASSOCIATE PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY
KIMS, HUBLI.
11.2 SIGNATURE
11.3 CO-GUIDE IF ANY
11.4 SIGNATURE OF CO-GUIDE
11.5 HEAD OF THE DEPARTMENT: /

DR.SAFIYA. I.SHAIKH.M.D.

PROFESSOR AND HEAD OF THE DEPARTMENT OF ANAESTHESIOLOGY

KIMS, HUBLI

11.6 SIGNATURE:
12. / 12.1 REMARKS OF THE CHAIRMAN AND THE PRINCIPAL
12.2 SIGNATURE