| CTRI Number |
CTRI/2024/01/061116 [Registered on: 04/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effect of ketamine and Paracetamol with Paracetamol alone on reduction of pain, nausea and vomiting after adenotonsil surgery in children |
|
Scientific Title of Study
|
A Comparative study of effect of administration of Ketamine and Paracetamol versus Paracetamol on postoperative pain, nausea and vomiting after pediatric Adenotonsillectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena Mathur |
| Designation |
HOD and Senior professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
HOD and Senior professor
Department of Anaesthesia
JLN Medical college
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Mathur |
| Designation |
HOD and Senior professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
HOD and Senior professor
Department of Anaesthesia
JLN Medical college
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Mathur |
| Designation |
HOD and Senior professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
HOD and Senior professor
Department of Anaesthesia
JLN Medical college
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN Medical College, Ajmer |
|
|
Primary Sponsor
|
| Name |
JLN Medical College |
| Address |
JLN Medical College
Ajmer, Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Reema Santhosh |
JLN medical college ,Ajmer |
ENT Operation theatre, 1st floor OPD COMPLEX
JLN Medical College.
Ajmer
Rajasthan
Ajmer
RAJASTHAN |
8113898887
reemalissysanthosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee JLN Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj ketamine (0.25mg/kg) and Inj paracetamol(15mg/kg) |
With due approval from institutional ethical committee, a prospective randomized double-blind study has been planned on 80 pediatric patients coming to ENT department for adenotonsillectomy posted for surgery in the operation theatre in the department of anesthesiology, JLN Medical College Ajmer. A written informed consent will be obtained from guardian of each patient after complete explanation about the study, protocol, anesthesia technique, merits and demerits of the procedure. Patients are given ketamine 0.25 mg/kg with paracetamol 15 mg/kg to one group and paracetamol 15 mg/kg to next group and outcome assessed postoperatively till 12 hours in hourly intervals |
| Comparator Agent |
Inj paracetamol (15mg/kg) |
With due approval from institutional ethical committee, a prospective randomized double-blind study has been planned on 80 pediatric patients coming to ENT department for adenotonsillectomy posted for surgery in the operation theatre in the department of anesthesiology, JLN Medical College Ajmer. A written informed consent will be obtained from guardian of each patient after complete explanation about the study, protocol, anesthesia technique, merits and demerits of the procedure. Patients are given ketamine 0.25 mg/kg with paracetamol 15 mg/kg to one group and paracetamol 15 mg/kg to next group and outcome assessed postoperatively till 12 hours in hourly intervals. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective adenotonsillectomy
ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Age<2 years and > 12 years
Emergency surgery
Patient refusal
Patient sensitive/ allergic to any of the drugs
Patient with neuropsychiatric illness
cardiovascular disease patient
Coagulopathies
Hepatic and Renal disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia and assesesment of pain. |
Assessment of Children Hospital of Eastern Ontario Pain Scale (CHEOPS) in young children in postoperative period at immediatly after extubation,15 min, 30 min, 1hr,2hr,4hr,6hr and 12 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of postoperative analgesia
Postoperative nausea & vomiting (PONV) |
Assessment of time of demand of rescue analgesia.
Assessment of episodes of nausea & vomiting after extubation, 15 min, 30 min,1 hr,2 hr,4 hr,6 hr & 12 hour. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a hospital based prospective, randomized, double blind study conducted to compare the efficacy of administration of Ketamine and Paracetamol versus Paracetamol on postoperative pain, nausea, vomiting after pediatric adenotonsillectomy. For this study pediatric population is between 3 to 12 years of age group ASA grade 1 or 2 with exemption of all the exclusion criteria mentioned above and undergoing adenotonsillectomy under general anesthesia. The primary objective of the study is to assess the postoperative 12-hour pain score after administrating the drugs. The secondary objective of the study is to assess the duration of analgesia, episodes of nausea and vomiting, hemodynamic status before and after giving the analgesics and any complication associated. Participants will be allocated in two different group each with 40 number sample size. Group KP will receive Injection Ketamine (0.25mg/kg) with Paracetamol (15mg/kg) intravenously and group P will receive injection Paracetamol (15mg/kg). Both the drugs are administrated 15 minutes prior to the extubation. Preanesthetic evaluation will be done on the day before surgery. Since the patient enrolled in the surgery were children, patents need to give full information regarding the study with informed risk consent. All preparation for general anesthesia with emergency cart will be kept ready in prior. Child will be induced after proper preoxygenation and premedication and later with muscle relaxant in adequate dosage at optimum depth of anesthesia. Child will be administrated with above mentioned drugs 15 minutes prior to extubation. Patient will be monitored intraoperatively and postoperatively upto12 hours at pre described time interval and documented. Data will be analyzed statistically using standard quantitative and qualitative tests. |