| CTRI Number |
CTRI/2018/03/012878 [Registered on: 27/03/2018] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To compare fentanyl and ketamine as pain relief agent in preterm babies requiring laser treatment for retinopathy of prematurity(ROP) |
|
Scientific Title of Study
|
Fentanyl versus ketamine for analgesia during laser treatment for retinopathy of prematurity(ROP) in preterm infants- An interventional case series study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shamnad M |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Neonatology
Department of Pediatrics
Ansari Nagar
AIIMS
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
shamnadmadathil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Agarwal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Neonatology
NHKC, NPW first floor
Ansari Nagar
AIIMS
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
ra.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shamnad M |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Neonatology
Department of Pediatrics
Ansari Nagar
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
shamnadmadathil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Division of Neonatology |
| Address |
Newborn Health Knowledge Centre
New Private Ward first floor
AIIMS, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 |
| Shamnad M |
AIIMS, New Delhi |
Division of Neonatology,
NHKC, NPW first floor,
AIIMS,
Ansari Nagar
New Delhi
110029
New Delhi
DELHI |
9990048228
shamnadmadathil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Retinopathy of prematurity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl |
Establish intravenous access under strict aseptic precautions.Give bolus dose of fentanyl at 2 mcg/kg 15 minutes prior to procedure. Following bolus, fentanyl infusion at 1 mcg/kg/hour will be started.If there is no response as assessed by increased crying, baby starting to move excessively or tachycardia defined as change in heart rate persistently 24 from baseline during the procedure, increase the dose by 0.5 mcg/kg/hour every 15 minutes to a maximum of 3 mcg/kg/hour
|
| Intervention |
Ketamine |
Establish intravenous access under strict aseptic precautions.Give bolus dose of ketamine at 0.5 mg/kg 1 minute prior to procedure.All infants allocated to ketamine group will be loaded with bolus 0.5 mg/kg. If there is no response as assessed by increased crying, baby starting to move excessively or tachycardia defined as change in heart rate persistently 24 from baseline during the procedure, intermittent bolus doses of 0.5 mg/kg will be given every 10 minutes till a maximum of 2 mg/kg
|
| Comparator Agent |
Not applicable |
Not applicable. As we do not know which agent is superior , no comparator arm is taken. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
90.00 Day(s) |
| Gender |
Both |
| Details |
All preterm infants attending clinic at RP Center for laser therapy for ROP
a) Declared fit for undergoing laser therapy
b) Anticipated duration of procedure > 30 minutes
c) Hemodynamically stable
d) No anemia( PCV>30)
e) Absence of major morbidities [Grade III-IV intraventricular hemorrhage(IVH), (patent ductus arteriosus(PDA), necrotizing enterocolitis(NEC)]
|
|
| ExclusionCriteria |
| Details |
a) Babies with congenital malformations
b) Babies already on CPAP, MV or sick enough to require NICU care
c) Babies with hypertension
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Revised PIPP score 5 minutes before and then every 15 minutes during the procedure in preterm infants undergoing laser photocoagulation for ROP
2. Total duration of cry/ % cry time during procedure
|
5 minute before and every 15 minutes during the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for NICU/HDU admission for 24 hours or more post procedure as defined by any of the following
a) Change in mean cardiorespiratory stability scores after procedure requiring upgradation of respiratory support
b) Hemodynamic instability within 24 hours of procedure requiring fluid boluses or vasoactive support
c) Intolerance to feeds post procedure
d) Urinary retention requiring bladder catheterization
e) Repeated episodes of apnea
|
24 hours post procedure |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="124" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/04/2018 |
| Date of Study Completion (India) |
10/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Laser photocoagulation of retina has now become the standard of care for retinopathy of prematurity (ROP) in preterm infants. It is a stressful and painful procedure. However little attention is paid towards strategies for pain reduction in neonates. The standard of care for analgesia during laser treatment is either general anesthesia (GA) or a combination of sedation, analgesia and paralysis (SAP). Due to lack of adequately trained personnel and huge patient load, most of the neonatal units in India are doing laser therapy without any pharmacological analgesia or general anaesthesia so as to avoid mechanical ventilation. A recent RCT conducted in our unit which evaluated the efficacy of low dose opioid(fentanyl) infusion compared to 24% dextrose during ROP laser photocoagulation showed that although opioid analgesia was superior, proportion of time spent during crying and pain scores assessed by premature infant pain profile (PIPP) scores were still higher even with low dose opioid infusion. That is why this study is being done to determine the efficacy and safety of fentanyl infusion and ketamine sedation as a potential regime for reduction of pain associated with laser photocoagulation for ROP without increasing need for ventilation and duration of hospital stay in these infants. |