| CTRI Number |
CTRI/2025/06/089808 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In this study we compare two different drugs dexmedetomidine and
ketamine with paracetamol to see their ability to reduce pain in children born before completion of term undergoing laser photocoagulation surgeries for retinopathy of prematurity |
|
Scientific Title of Study
|
Opioid free analgesia using Dexmedetomidine vs Ketamine in infants with Retinopathy of Prematurity undergoing laser photocoagulation surgeries |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vanparthi Anjali Gupta |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Anaesthesia office ,Department of Anaesthesiology and intensive care,Nehru hospital,PGIMER, Sector 12, Madhyamarg Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7901015647 |
| Fax |
|
| Email |
anjali.vanparthi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanvir Samra |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Anaesthesia office ,Department of Anaesthesiology and intensive care,Nehru hospital,PGIMER, Sector 12, Madhyamarg Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087262379 |
| Fax |
|
| Email |
drtanvirsamra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvir Samra |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Anaesthesia office ,Department of Anaesthesiology and intensive care,Nehru hospital,PGIMER, Sector 12, Madhyamarg Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087262379 |
| Fax |
|
| Email |
drtanvirsamra@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research,Sector 12,Madhyamarg,
Chandigarh,160012,India |
|
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Primary Sponsor
|
| Name |
Director of Postgraduate Institute of Medical Education and Research |
| Address |
PGIMER, Sector 12, Madhyamarg, Chandigarh, 160012 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vanparthi Anjali Gupta |
PostGraduate Institute of Medical Education and Research |
Advanced Eye Centre Operation theatre,4th floor, PGIMER,
sector 12,Madhyamarg,Chandigarh,160012
Chandigarh
CHANDIGARH |
7901015647
anjali.vanparthi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute Of Medical Education and Research,Chandigarh,INSTITUTE ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
Dexmedetomidine administered as a loading dose of 0.5 mcg/kg in first
10 mins followed by a continuous infusion of 0.7 mcg/kg/hr which will be titrated
based on haemodynamic response to a maximum of 2mcg/kg |
| Intervention |
KETAMINE |
Ketamine administered as an intravenous bolus prior to the procedure
of 1-2mg/kg in the first 10 mins followed by infusion at 0.1mg/kg/h to a maximum of
0.25mg/kg/h |
| Comparator Agent |
PARACETAMOL |
PCM for neonates upto 37 weeks post conception age 7.5mg/kg, 37
weeks and above 10mg/kg will be given as an infusion for 10 mins |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Preterm infants less than 37 weeks of gestational age diagnosed with ROP requiring laser treatment. |
|
| ExclusionCriteria |
| Details |
1. Infants with contraindications to dexmedetomidine or ketamine.
2. Infants already on any type of respiratory support or sick enough to be in NICU.
3. Infants with any congenital abnormalities.
4. Refusal to take part in study. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare pain scores at 5 mins post laser photocoagulation surgeries in infants
using premature infant pain profile(PIPP). |
1min, 5 mins,10mins,30mins post laser photocoagulation surgeries in infants
using premature infant pain profile(PIPP). |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative hemodynamic stability, adverse effects (apnea,bradycardia)
and the time of awakening post procedure. |
Baseline, every 5 mins intraoperatively postoperatively till 30 mins. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 1 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Retinopathy of prematurity (ROP) is a condition of retinal vascular and capillary growth that affects premature newborns on oxygen therapy.Laser photocoagulation is one of the available treatment options. Laser therapy can be done under deep sedation or general anaesthesia. Exposure to anaesthesia obtunds the compensatory respiratory mechanisms in preterm causing early desaturation in preterm neonates. Apnea of prematurity is a development disorder in infants less than 37 weeks and is due to underdeveloped respiratory control in infants. Use of opioids increases the incidence of respiratory depression. Preterm infants xperiencing pain during performance of multiple procedures in NICU nasogastric tube insertion, cannulations, chest tube insertions etc have poorer motor and cognitive outcomes.Thus, various non pharmacological methods of pain management like nesting, swaddling, non nutritive sucking, facilitated tucking, kangaroo mother care etc and pharmacological methods like administration of non analgesic(sucrose, dextrose) and analgesic drugs (opioids, acetaminophen) have been popularized in pediatric patients. The mainstay of management for ROP involves the painful process of laser photocoagulation, which ablates the retinal vessels. Ketamine is one such non opioid analgesic. Ketamine is a phencyclidine derivative that acts as a noncompetitive N-methyl-D-aspartate as well as a glutamate receptor antagonist. Dexmedetomidine is a highly selective alpha2-agonist with greater affinity to alpha2 than alpha 1 with a ratio of 1600:1, dexmedetomidine produces sedation that mimics natural sleep, anxiolysis, sympatholysis, and an anaesthetic-sparing effect without causing respiratory depression that is clinically significant All the infants enrolled in the study,would undergo preanaesthetic evaluation. NPO Guidelines include abstaining from formula feed for 6 hours or breast milk for at least 4 hours and clear fluids for at least 2 hrs prior to surgery. In the OT, routine ASA monitoring would be done including electrocardiogram (ECG), pulse oximetry (Spo2), non-invasive blood pressure (NIBP), temperature (TEMP) and ETCO2. IV line will be secured after application of EMLA cream. Suitable face masks, according to each patient’s age and weight, will be kept. Preoxygenation with 100% oxygen will be done. Loading dose of Dexmedetomidine or Ketamine or PCM will be given in infusion over 10 mins according to the group allocated. Anaesthesia induction will be performed either with the inhalational agent sevoflurane, gradually increased from 2% to 8%, or with propofol at a dosage of 2-3mg/kg IV, titrated to achieve a MAC of 1-1.3 or BIS 40-60, utilizing a closed anesthesia circuit. Following confirmation of the ability to ventilate, an appropriateatracurium dosage of 0.5 mg/kg IV will be administered to achieve neuromuscular relaxation followed by which child will be intubated with ET tube of appropriate size after 4 minutes according to the age and weight of the child. After induction the infants in group DEX will be maintained on dexmedetomidine at an infusion of 0.7mcg/kg/hr, infants in group KETA are maintained on ketamine at an infusion of 0.1mg/kg/hr and titrated according to haemodynamic stability, the infant will be maintained using sevoflurane, oxygen and nitrous oxide mixture intraoperatively, intraoperative vitals are noted at 5 mins interval to assess the intraoperative pain, inadequate response will be seen as a 20% increase or decrease of heart rate from the baseline after ruling out other reversible causes. Pain in the post operative period will be assessed using the PIPP scale at 1, 5, 15 and 30 mins. In case of pain the infant in group DEX and group KETA will be given PCM as required.
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