| CTRI Number |
CTRI/2023/07/055556 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Intranasal fentanyl as add-on therapy in screening of retinopathy of prematurity - to reduce the pain associate with rop screening
|
|
Scientific Title of Study
|
"Intranasal fentanyl as add-on therapy in screening of retinopathy of prematurity - A double blind 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 |
Dr Sandip kumar sahu |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTUTITE OF MEDICAL SCIENCES, BHUBANESWAR |
| Address |
ALL INDIA INSTUTITE OF MEDICAL SCIENCES, BHUBANESWAR DEPARTMENT OF OPHTHALMOLOGY,ACADEMIC BLOCK 4th floor ,Room no 411 Sijua,patrapada
,odisha
Khordha
ORISSA
751019
India |
| Phone |
7978243970 |
| Fax |
|
| Email |
drsandipsahu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandip Sahu |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTUTITE OF MEDICAL SCIENCES, BHUBANESWAR |
| Address |
ALL INDIA INSTUTITE OF MEDICAL SCIENCES, BHUBANESWAR DEPARTMENT OF OPHTHALMOLOGY,ACADEMIC BLOCK 4th floor ,Room no 411 Sijua,patrapada
,odisha
Khordha
ORISSA
751019
India |
| Phone |
7978243970 |
| Fax |
|
| Email |
drsandipsahu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debasish sadangi |
| Designation |
Junior resident |
| Affiliation |
ALL INDIA INSTUTITE OF MEDICAL SCIENCES, BHUBANESWAR |
| Address |
ALL INDIA INSTUTITE OF MEDICAL SCIENCES, BHUBANESWAR DEPARTMENT OF OPHTHALMOLOGY,ACADEMIC BLOCK 4th floor ,Room no 411 Sijua,patrapada
,odisha
Khordha
ORISSA
751019
India |
| Phone |
7978051934 |
| Fax |
|
| Email |
sadangi.debasish@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR SANDIP KUMAR SAHU |
| Address |
DEPARTMENT OF OPHTHALMOLOGY,AIIMS,BHUBANESWAR
|
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Dr Sandip Kumar Sahu |
AIIMS Bhubaneswar |
DEPARTMENT OF NEONATOLOGY,NICU,AIIMS BHUBANESWAR
Khordha
ORISSA |
7978243970
drsandipsahu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,AIIMS BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal fentanyl[2µg/kg] |
(breast milk to be given to child 30 minute before the screening and 0.5% proparacaine eye drop to put 1 minute before screening) standard screening procedure add with fentanyl 2microgram per kg as add-on therapy through intranasal route 10 minutes before the screening (by using mucosal atomization device)
|
| Comparator Agent |
Normal Saline |
(breast milk to be given to child 30 minute before the screening and 0.5% proparacaine eye drop to put 1 minute before screening)standard screening procedure add with normal saline through intranasal route 10 minute before the screening start (by using mucosal atomization device)
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
Preterm infants heaving gestational age
<34 weeks or birth weight< 2000 gm were screened for retinopathy of prematurity
|
|
| ExclusionCriteria |
| Details |
Unstable neonates ( ventilate) and sedated neonate
Neonates with C/I for fentanyl
Neonates planned for surgery and neonate with congenital defects, and neurological disfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - To compare the effects of intranasal fentanyl (I) with standard care (C) in reducing procedural pain related to ROP screening (O) in preterm neonates (P) to be evaluated by the premature infant pain profile - R (PIPP-R) score |
immediately after screening,1 minute after screening,5 minute after screening |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. . To compare the incidences of ocular and systemic side effect in neonates(due to intra nasal fentanyl) like apneic episodes, need of respiratory support and episodes of bradycardia & desaturation between the groups
2.To compare the time taken to complete the procedure successfully in both
|
patient was kept under abservation for next 24 hour to look out for any ocular and systemic,and local side effect |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
30/07/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Retinopathy of prematurity (ROP) affects premature LBW infants. Early exposure to high ambient oxygen concentration appears to be a risk factor. systemic conditions like RDS, sepsis , any kind of blood transfusion and anemia also play a key role. Nasal retina vascularizedafter 8 months of gestation and temporal after 1 month of delivery. Retinopathy of prematurity evolves through two phases. It begins with delayed vascular growth after premature birth (phase 1). Phase 2 follows when phase 1 induced hypoxia releases factor to stimulate new blood vessel growth. vascular epithelial growth factor (VEGF) is thought to play important role in this. genesis of ROP Screening for ROP is an standard age-old practice in neonate ICU. Premature neonates experience a considerable amount of pain owing to speculum ROP screening from the insertion of a speculum, scleral indentation, and from the illumination of the ophthalmoscope. So here the pain are multimodal.(1) ROP screening produces short-lasting pain which is experienced mainly by non-ventilated neonates. The healthcare personnel have to depend on behavioral and physiological responses of neonates to grade the distress and pain cause during screening as they cannot verbalize their pain. For the purpose of screening the pupil of the premature infants dilated with 0.8% tropicamide and 2.5% phenylephrine. topical anesthetics are installed and Topical anesthetic drop (proparacaine) is instilled before application of the neonatal eyelid eye speculum is used. Local anesthetic eye drops, swaddling, skin to skin care, gauge socked with expressed breast milk, non-nutritive sucking, have been evaluated in many clinical trials over past decade found to be inadequate effects on the pain associated with retinopathy of prematurity (ROP) screening. Meta-analyses study also concur that no single intervention was absolutely effective in reducing pain in ROP screening. The most optimal approach to relief the pain associated with retinal examination could be through engage in cluster of interventions, including analgesic medications. (1) In pediatric patient Intranasal fentanyl is found to be safe and well-tolerated as analgesic method in pre-and post-operative pain control. The moa of fentanyl is it mainly acts through mu-opioid receptor. This route is a fast and easy way to achieve a clinically effective blood level |