FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066305 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 31/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Efficacy of existing drugs ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effect of combined use of intravenous fentanyl and intravenous ketamine against use of intravenous fentanyl for reducing pain associated with the laser photocoagulation procedure done for retinopathy of prematurity in preterm neonates 
Scientific Title of Study   combination of intravenous fentanyl and ketamine vs intravenous fentanyl for analgesia during laser photocoagulation in retinopathy of prematurity in preterm neonates: A randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bairapaga Harshini 
Designation  Senior resident  
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  Room no. 811, C wing, 8th floor, Mother and Child block , Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi.

South
DELHI
110029
India 
Phone  8790873532  
Fax    
Email  harshinibairapaga77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankit Verma  
Designation  Associate professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Room no. 811, C wing, 8th floor, Mother and Child block , Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi.

South
DELHI
110029
India 
Phone  8447343609  
Fax    
Email  ankitvmmc@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Bairapaga Harshini 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  Room no. 811, C wing, 8th floor, Mother and Child block , Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi.

South
DELHI
110029
India 
Phone  8790873532  
Fax    
Email  harshinibairapaga77@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari nagar East, South New Delhi India 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansari Nagar East South New Delhi India 110029 
Type of Sponsor  Government medical college 
 
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 
Dr Ankit Verma  All India Institute Of Medical Sciences  Room no 811 C Wing 8th floor Mother and Child Block Division of Neonatology Department of paediatrics AIIMS Delhi South Delhi
South
DELHI 		 8447343609

ankitvmmc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for post graduate research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H351||Retinopathy of prematurity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination of intravenous fentanyl and ketamine   Intravenous loading dose of fentanyl (2 mcg/kg) and ketamine (0.5 mg/kg) bolus followed by intravenous fentanyl infusion of 2 mcg/kg/hour to a maximum 5mcg/kg/hour and intermittent intravenous bolus doses of ketamine 0.5 mg/kg to a maximum of 4mg/kg by monitoring the PIPP R score every 15minutes during the procedure, until the completion of the procedure(laser photocoagulation for retinopathy of prematurity) Dose will be increased if PIPP R score is 7(assessed every 15 minutes during the procedure until completion) Same dose will be continued if PIPP R is 7(assessed every 15 minutes during the procedure until completion) Duration of procedure will vary from patient to patient and depend upon treating ophthalmologist  
Comparator Agent  intravenous fentanyl  Intravenous fentanyl loading dose, 2 microgram per kilogram per bolus followed by intravenous infusion of 2 microgram per kilogram per hour to a maximum of 5 microgram per kilogram per hour by monitoring the PIPP R score every 15 minutes during the procedure, until the completion of the procedure which is laser photocoagulation for retinopathy of prematurity Dose will be increased if PIPP R score is more than 7 and will be assessed every 15 minutes during the procedure until completion Same dose will be continued if PIPP R is less than or equal to 7 and will be assessed every 15 minutes during the procedure until completion Duration of procedure will vary from patient to patient and depend upon treating ophthalmologist  
 
Inclusion Criteria  
Age From  28.00 Day(s)
Age To  8.00 Month(s)
Gender  Both 
Details  All preterm neonates more than 1500g at the time of screening on room air for past 3 days and hemodynamically stable requiring laser photocoagulation for zone 2 ROP 
 
ExclusionCriteria 
Details  Major malformations severe birth asphyxia shock
Known chromosomal abnormality
History of chest wall rigidity with fentanyl
by screening the records
History of any opioid use in the last 7 days
Known hydrocephalus or glaucoma
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of neonates having adequate pain relief defined as PIPP R score less than 7 for at least fifty percentage of the time during the procedure  5 minutes prior to the procedure and then every 15 minutes during the procedure  
 
Secondary Outcome  
Outcome  TimePoints 
To determine the side effect profile of combination of fentanyl infusion and intermittent ketamine bolus   All the apneic events will be recorded
 
To determine occurrence of feed intolerance  Two hourly till twelve hours post procedure 
To determine requirement of ventilatory support  From the start of procedure to twenty four hours after the procedure 
To determine occurrence of urinary retention  six hourly till twenty four hours post procedure 
To determine occurrence of hemodynamic instability within twenty four hours of procedure  Two hourly till twelve hours post procedure 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) 03/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Any preterm neonate more than 1500 gm requiring retinopathy of prematurity screening found to have zone 2 ROP planning for laser photocoagulation, meeting the inclusion criteria will be enrolled in this study after obtaining informed written consent from the parents. If consented babies will be randomised to one of the two arms (fentanyl and ketamine Vs fentanyl). Before the procedure non pharmacological measures, along with local anaesthetic eyedrops will be instilled. Baseline PIPP-R score will be done and bolus dose of the drugs will be given as per the arms chosen by randomisation. During the laser the drugs will be titrated as per the PIPP-R score, and baby will be continuously monitored throughout the procedure until discharge for any adverse events and will be managed with appropriate measures.

 
Close