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
|
|
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
|
|
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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