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CTRI Number  CTRI/2024/06/069308 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   comparision of low doses of spinal injection of morphine for postopertative pain relief in pediatrics surgeries  
Scientific Title of Study   Comparison of low doses of intrathecal morphine for postoperative analgesia A prospective randomized double blinded comparative study  
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 Heena Purshotamdas Bhupta  
Designation  Pediatrics Anaesthesia Fellow  
Affiliation   
Address  Rainbow Childrens hospital and birthright road no 2 banjara hills Department of Anaesthesia 4th Floor pediatrics operation theater
Rainbow Childrens hospital and birthright road no 2 banjara hills Department of Anaesthesia 4th Floor pediatrics operation theater
Hyderabad
TELANGANA
500034
India 
Phone  09985153921  
Fax    
Email  heena.bhupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Heena Purshotamdas Bhupta  
Designation  Pediatrics Anaesthesia Fellow  
Affiliation   
Address  Rainbow childrens hospital and birthright road no 2 banjara hills Department of anaesthesia 4th floor pediatrics opertaion theater
Rainbow childrens hospital and birthright road no 2 banjara hills Department of anaesthesia 4th floor pediatrics opertaion theater
Hyderabad
TELANGANA
500034
India 
Phone  09985153921  
Fax    
Email  heena.bhupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Heena Purshotamdas Bhupta  
Designation  Pediatrics Anaesthesia Fellow  
Affiliation   
Address  Rainbow childrens hospital and birthright road no 2 banjara hills Department of anaesthesia 4th floor pediatrics opertaion theater
Rainbow childrens hospital and birthright road no 2 banjara hills Department of anaesthesia 4th floor pediatrics opertaion theater
Hyderabad
TELANGANA
500034
India 
Phone  09985153921  
Fax    
Email  heena.bhupta@gmail.com  
 
Source of Monetary or Material Support  
Rainbow childrens hospital and birthright road no 2 banjara hills Department of anaesthesia 4th floor pediatrics opertaion theater  
 
Primary Sponsor  
Name  Rainbow Childrens hospital and birthright 
Address  banjara hills road number 2  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gita Nath   Raimbow Childrens Hospital and Birthright   Banjara Hills road number 2 Department of Anaesthesia, 4th floor, pediatrics operation theater pincode 5000034
Hyderabad
TELANGANA 
9000241012

drgitanath@hotmail.com 
Dr Heena Purshothamdas Bhupta   Raimbow Childrens Hospital and Birthright   Banjara Hills road number 2 Department of Anaesthesia, 4th floor, pediatrics operation theater pincode 5000034
Hyderabad
TELANGANA 
9985153921

heena.bhupta@gmail.com 
Dr Shilpa SN  Raimbow Childrens Hospital and Birthright   Banjara Hills road number 2 Department of Anaesthesia, 4th floor, pediatrics operation theater pincode 5000034
Hyderabad
TELANGANA 
9916275903

shilpa.sn.bly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RAINBOW CHILDRENS HOSPITAL EC FOR BIOMEDICAL AND HEALTH RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MOPPHINE   This study aims to compare the efficacy of low doses that is 2mcg/kg and 5mcg/kg of intrathecal morphine for adequate postoperative analgesia with minimal side effects. The participant will be monitored for 24 hours to assess for analgesia via FLACC and NRS, nausea and vomiting, respiratory depression, desaturation and urinary retention.  
Comparator Agent  MORPHINE   The ideal dose of intrathecal morphine in pediatrics as a mode of post operative analgesia is yet to be established. In the past widely varied doses have been used with greater incidence of side effects with higher doses. Since there is ceiling effect with increasing doses, finding an effective dose while minimizing side effects would be advantageous.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All pediatric patients above 1 year of age, ASA 1-2 undergoing elective and emergency major surgeries which includes laparotomies, orthopedic surgeries of lower limbs 
 
ExclusionCriteria 
Details  less than 1 year of age
headn and neck surgeries
deranged coagulation profile
day care
refusal to consent by parents
spine deformities  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare the efficacy of 2mcg per kg and 5mcg per kg of intrathecal morphine for postopertaive analgesia.   patient will be assessed for 24 hours after injection of intrathecal morphine for analgesia and other side effects of morphine.  
 
Secondary Outcome  
Outcome  TimePoints 
postoperative nausea and vomiting   24 hours  
urinary retention in noncatheterised patients   24 hours  
respiratory depression   24 hours  
pruritis   24 hours  
desaturation   24 hours  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   01/07/2024 
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="0"
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 is a prospective randomised double blinded study, with computer generated randomisation. The patient will be allotted into group A or B representing 2mcg/kg and 5mcg/kg morphine dose.

      PREOPERATIVE:

·      Routine clinical practice will be followed in all surgical cases as per institutional protocol. Data will be collected including patient characteristics- age, sex, height, weight, medical registration number etcetera, medical history- ASA physical status and comorbidities. Surgery- procedure and whether elective or emergency and coagulation profile also be noted. Patients will be recruited for the study only after obtaining written and verbal consent from the parents

INTRAOPERATIVE:

·      Baseline vitals will be noted. Routine induction will be done with IV Fentanyl 2 mcg/kg, IV Propofol 2-3 mg/kg and paralyzed with IV Rocuronium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained with sevoflurane with air and oxygen mixture on low flow anesthesia. Patient will be positioned left lateral for intrathecal morphine injection. Under aseptic precautions, intrathecal morphine will be injected at L2-L3 space using 25G pencil point needle. Morphine will be diluted in 2 ml normal saline and injected once free flow of CSF is seen.  

·      Observation: Post intrathecal morphine vitals will be documented every 5 mins in the first 30 mins and every 15 mins thereafter. A 20% or more increase in heart rate will be considered as “response to surgical stimulus”.

·      Analgesia: IV Paracetamol 15mg/kg and Diclofenac suppository 1mg/kg will be given to all patients as per institutional protocol. Intraoperatively IV Fentanyl may be increased further as rescue analgesia and it will be documented.

 

      POSTOPERATIVE:

·      After extubation patient will be observed in the Post Anaesthesia Care Unit (PACU) until the patient is fully awake and tolerating oral feed.

·      Vitals will be monitored and recorded every 15 mins in the first hour and every 30 mins in the second hour in the PACU.

·      IV Fentanyl 1mcg/kg will be given as rescue analgesia in the PACU. Paracetamol 15  mg/kg TID IV or oral will be prescribed to the patient after being discharged from the PACU. The nursing staff will monitor pain score every 3rd hourly. A FLACC score of >1 or Wong Baker faces scale of >2 or Numerical Pain score (NRS) >2 will be an indication for rescue analgesia. Tramadol 1 mg/kg oral or IV will be given as rescue analgesia in the ward.

·      Patient will be followed up for 24 hours in the post operative period. Nurse’s notes will be checked for vitals, pain score, nausea, and vomiting, pruritis of every hourly recorded by nursing staff. The primary investigator will follow up at 6, 12, 18, 24 hrs from the time of intrathecal morphine by calling up the respective ward. Time of rescue analgesia will also be noted.

·      The following questions will be asked to the nursing staff during the follow up:

1.     FLACC / Wong Baker faces pain score

2.     NRS pain score

3.     Nausea and vomiting

4.     Pruritis

5.     Urinary retention

6.     Saturation

7.     Any other event


Definition of Post Operative Nausea and Vomiting (PONV):

 

Nausea is a nonobservable phenomenon of an unpleasant sensation experienced in the back of the throat and the epigastrium that may or may not culminate in vomiting.

Retching is an attempt to vomit without bringing anything up.

Vomiting is a forceful expulsion of gastric contents orally or nasally. PONV describes as nausea, vomiting, retching that can occur starting the PACU and continuing through 24 hours after surgery.

Patient will be observed for the following:

·      No retching, no vomiting

·      Retching but no vomiting

·      Vomiting  

Treatment: to be given to patients with retching / vomiting.  

First line: IV Ondansetron 0.1 mg/kg

Second line: IV Dexamethasone 0.1 mg/kg

 

Definition of urinary retention:

 

Post operative Urinary Retention (POUR) is the inability to void urine for >12 hours in the presence of palpable urinary bladder. Patients may complain of suprapubic pain or discomfort, visible abdominal distention maybe present due to overdistended bladder.

Treatment: Catheterisation

 

Definition of pruritis:

 

Itching is an unpleasant sensation that leads to the desire to scratch. It is a subjective feeling and the objective measurement of it could be a challenge. Numerical Rating Scale (NRS)  for pruritis is the most commonly used assessment for pruritis.

 

Treatment:

Mild to moderate pruritis - local application of Lactocalamine lotion

If not resolved, Tab. Cetirizine 5mg will be prescribed  

Severe pruritis- IV. Naloxone 0.1 mg/kg/dose, this will be diluted in 10 cc syringe and aliquots of 10 mcg or 1 ml of Naloxone will be given every 2-3 mins until itching is resolved

Definition of Respiratory depression:

 

Respiratory rate of <10 per minute or saturation <93% or both will be considered as respiratory depression.

Treatment: administration of oxygen via face mask or nasal prongs.

If respiratory rate <10 per minute breaths will be assisted with IPPV with bag and mask, painful stimulus and Inj Naloxone 0.1 mg/kg/dose, this will be diluted in 10 cc syringe and aliquots of 10 mcg or 1ml of Naloxone will be given every 2-3 mins until respiratory depression is resolved.


 
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