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CTRI Number  CTRI/2021/09/036376 [Registered on: 09/09/2021] Trial Registered Prospectively
Last Modified On: 07/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To see if nasal application of Dexmedetomidine will increase the pain free interval after caudal block in children undergoing infra-umbilical surgeries  
Scientific Title of Study   Effect of Instillation of Intranasal Dexmedetomidine on the Duration of Caudal Analgesia in Paediatric Infra-Umbilical Surgeries  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ganga Prasad  
Designation  Professor 
Affiliation  AIIMS Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS New Delhi

South
DELHI
110029
India 
Phone  9013232965  
Fax    
Email  drgpd@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Ganga Prasad  
Designation  Professor 
Affiliation  AIIMS Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS New Delhi


DELHI
110029
India 
Phone  9013232965  
Fax    
Email  drgpd@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Saira Susan Mathew 
Designation  Junior Resident 
Affiliation  AIIMS Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS New Delhi

South
DELHI
110029
India 
Phone  9074573287  
Fax    
Email  sairah.mathew@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS) Ansari Nagar New Delhi- 110029  
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS New Delhi  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ganga Prasad  AIIMS Delhi  Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS New Delhi
South
DELHI 
9013232965

drgpd@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee,AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N399||Disorder of urinary system, unspecified, (2) ICD-10 Condition: N358||Other urethral stricture, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: P789||Perinatal digestive system disorder, unspecified, (5) ICD-10 Condition: Q626||Malposition of ureter, (6) ICD-10 Condition: Q541||Hypospadias, penile, (7) ICD-10 Condition: Q542||Hypospadias, penoscrotal, (8) ICD-10 Condition: Q549||Hypospadias, unspecified, (9) ICD-10 Condition: Q543||Hypospadias, perineal, (10) ICD-10 Condition: Q641||Exstrophy of urinary bladder, (11) ICD-10 Condition: Q640||Epispadias, (12) ICD-10 Condition: Q420||Congenital absence, atresia and stenosis of rectum with fistula, (13) ICD-10 Condition: Q422||Congenital absence, atresia and stenosis of anus with fistula, (14) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (15) ICD-10 Condition: Q649||Congenital malformation of urinarysystem, unspecified, (16) ICD-10 Condition: Q643||Other atresia and stenosis of urethra and bladder neck, (17) ICD-10 Condition: Q559||Congenital malformation of male genital organ, unspecified, (18) ICD-10 Condition: Q623||Other obstructive defects of renalpelvis and ureter, (19) ICD-10 Condition: Q627||Congenital vesico-uretero-renal reflux, (20) ICD-10 Condition: Q625||Duplication of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intra nasal Instillation of Dexmedetomidine with caudal block  After standard induction of general anaesthesia, child will be positioned laterally, using landmark technique caudal block will be placed, caudally 0.25% 1ml/kg body weight ropivacaine would be given. Once caudal block is completed the child would be supine and intranasally 1mcg/kg body weight Dexmedetomidine will be instilled drop by drop into both nostrils until preloaded drug finishes. A delay of at least 15 mins will be kept between completion of caudal block and surgical incision. Intraoperative injection paracetamol according to weight will be given. Intra-operatively vitals will be monitored and noted every 5 mins (Heart Rate, Mean Arterial Pressure, Oxygen saturation and M.A.C). Upon completion of surgery after return of spontaneous ventilatory efforts, reversal will be administered. SAD or endotracheal tube will be removed upon fulfilling the extubation criteria. Total duration of surgery and anaesthesia will be noted. Patient will be assessed for Pain using FLACC score, sedation using Ramsey score & post operative emergence delirum using WATCHA score just after extubation. Patient will be shifted to recovery room and monitored for a period of 6 hours post-operatively. Heart rate, Respiratory rate, Sp02 will be continuously monitored in the PACU and recorded at 0 mins, 30 mins, 1 hr, 2 hr, 4 hr and 6 hr. Measurement of Pain using FLACC scale and Sedation using Ramsay sedation scale will be carried out at following intervals in PACU - 0 mins, 30 mins, 1 hr, 2 hr, 4 hr and 6 hr. Any side effects like Bradycardia, Hypotension, Desaturation, PONV, will be noted and treated accordingly. Further oxygen will be given if oxygen saturation decreases less than 95 percent. Supplemental analgesia as fentanyl 0.5 mcg/kg will be given when there is verbal complaint of pain or when FLACC score is more than 3. The patients will be observed for 10 mins after giving fentanyl and the dose will be repeated if there is still pain on assessment after 10 mins. The same dosage will be repeated in increments of 0.5mcg/kg till maximum of 2 mcg/kg. Duration of analgesia taken as time period between completion of caudal block and first analgesic administration post operatively will be measured.  
Comparator Agent  Intra nasal instillation of normal saline with caudal block  Caudal block with 0.25% Ropivacaine (1ml/kg body weight) + intranasal saline (similar volume to dexmedetomidine as per body weight). Above similar methodology for the control group except that the intra-nasal drug given would be normal saline which will be instilled in both nostril upon completion of caudal block with ropivacaine. Patient in the post-operative period will be monitored in PACU for 6 hours, where vitals, Pain and sedation will be monitored and recorded at intervals of 0 mins,30mins, 1 hr,2 hr,4 hr and 6 hr. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  a) Age: 1-7 years
b) ASA physical status grade I and II paediatric patients undergoing infra umbilical surgeries under General anaesthesia
 
 
ExclusionCriteria 
Details  a) Parental or guardian refusal.
b) Allergy or hypersensitivity to any drugs.
c) Known hypersensitivity to dexmedetomidine.
d) Pre-existing cardiovascular, respiratory,
cerebrovascular, neurological disease or coagulation
disorders.
e) Local infection at caudal puncture site.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the role of instillation of intranasal dexmedetomidine on duration of postoperative analgesia after caudal block in children undergoing Infra-umbilical surgical procedures.

 
From start of surgery to 6 hours post-operatively

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Post-operative emergence delirium using Watcha score.
2. Post-operative sedation using Ramsey sedation score.
3. Total analgesic consumption in first 6 hours.
4. Modified Aldrete score achieved at the end of 6 hours
postoperative.
5. Incidence of side effects like bradycardia, nausea &
vomiting and desaturation.
 
 
From start of surgery to 6 hours post-operatively

 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/09/2021 
Date of Study Completion (India) 31/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Caudal block is the most common regional anaesthetic technique employed in paediatric patients. Major limitation to single shot caudal block is its short duration. Many adjuvants have been tried to prolong the duration of analgesia but each of them have their own sets of side effects. Dexmedetomidine, a highly specific α2 agonist has been tried as an adjuvant through caudal and intravenous routes. Intranasal route of dexmedetomidine with a good bioavailability and similar duration of action as other two routes is still less explored. The current study is planned on fifty ASA 1,2 patients between the ages of one to seven years undergoing infra-umbilical surgeries under general anaesthesia. Upon fulfilling the inclusion and exclusion criteria the recruited patients, after an in depth pre anaesthetic check-up would be randomised into two groups where Group A (intervention group) would receive caudal block with 0.25% Ropivacaine (1ml/kg body weight) followed by intranasal instillation of dexmedetomidine (1mcg/kg body weight) and Group B (control group) would receive Caudal block with 0.25% Ropivacaine (1ml/kg body weight) followed by intranasal instillation of saline (similar volume to dexmedetomidine as per body weight) after induction of general anaesthesia. During the duration of surgery Heart Rate, Mean Arterial Pressure, Oxygen saturation and M.A.C would be monitored throughout and noted every 5 min until the completion of surgery. Upon completion of the surgery the patient would be extubated and will be shifted to PACU, where he/she will be monitored for a period of 6 hours. Upon extubation using the WATCHA score the patient would be assessed for post-operative delirium. In PACU Heart rate, Respiratory rate, Sp02 will be continuously monitored. Measurement of Pain and Sedation will be carried out at following intervals in PACU - 0 mins, 30 mins, 1 hr, 2 hr, 4 hr and 6 hr. Pain will be assessed using FLACC scale and Sedation will be assessed by Ramsey sedation score. Supplemental analgesia as fentanyl 0.5 mcg/kg will be given on self-reporting or when FLACC score > 3. The patients will be observed for 10 min and the dose will be repeated if there is still pain. The same dosage will be repeated in increments of 0.5mcg/kg till maximum of 2 mcg/hr. Total requirement of fentanyl will be noted. Duration of analgesia taken as time period between completion of caudal block and first analgesic administration will be measured. Any side effects like Bradycardia, Desaturation, PONV, excessive sedation, will be noted and treated throughout the period of study. Modified Aldrete score achieved at end of 6 hours will be noted where the study would conclude.

 

 

 

 

 

 

 
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