| CTRI Number |
CTRI/2017/12/011016 [Registered on: 28/12/2017] Trial Registered Prospectively |
| Last Modified On: |
20/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of single dose intranasal fentanyl for the reduction of pain associated with retinopathy of prematurity screening :RCT |
|
Scientific Title of Study
|
Single dose intranasal fentanyl for the reduction of pain associated with screening for retinopathy of prematurity : a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagdish Kathwate |
| Designation |
DNB (Neonatology) resident |
| Affiliation |
Surya Child Care PVT. LTD mumbai |
| Address |
Department of Neonatology, 4th floor, New building,
,
Junction of S V Road and Dattatraya Road,
Santacruz West,
Mumbai (suburban),
MAHARASHTRA
India
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
912261538990 |
| Email |
docjagdishkat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagdish Kathwate |
| Designation |
DNB (Neonatology) resident |
| Affiliation |
Surya Child Care PVT. LTD mumbai |
| Address |
Department of Neonatology, 4th floor, New building,
,
Junction of S V Road and Dattatraya Road,
Santacruz West,
Mumbai (suburban),
MAHARASHTRA
India
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
912261538990 |
| Email |
docjagdishkat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagdish Kathwate |
| Designation |
DNB (Neonatology) resident |
| Affiliation |
Surya Child Care PVT. LTD mumbai |
| Address |
Department of Neonatology, 4th floor, New building,
,
Junction of S V Road and Dattatraya Road,
Santacruz West,
Mumbai (suburban),
MAHARASHTRA
India
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
912261538990 |
| Email |
docjagdishkat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surya Child Care PVT. LTD
Department of Neonatology, 4th floor, New building,
Surya Child Care PVT. LTD,
Junction of S V Road and Dattatraya Road,
Santacruz West,
Mumbai (suburban),
MAHARASHTRA
400054
India
|
|
|
Primary Sponsor
|
| Name |
Surya Hospital |
| Address |
Department of Neonatology, 4th floor, New building,
Surya Child Care PVT. LTD,
Junction of S V Road and Dattatraya Road,
Santacruz West,
Mumbai (suburban),
MAHARASHTRA.India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 jagdish kathwate |
Surya Child Care PVT. LTD |
Junction of S V Road and Dattatraya Road,
Santacruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
7666490985
2261538990
docjagdishkat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical ethics committee(clinical research) Surya Children’s Medicare Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neonates 30-34 weeks postmenstrual age undergoing screening for retinopathy of prematurity., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Fentanyl (50mcg/ml) at a dose of 2 mcg / kg (diluted to 0.2 ml, 0.1 ml to each nostril) five minutes before eye examination
Available as Fenstud (Rusan Parma Ltd, India)
|
2 |
| Comparator Agent |
Intranasal normal saline (total 0.2 ml, 0.1 ml to each nostril) five minutes before eye examination
Both groups would receive standard pain relief measures (0.5ml of oral 24% sucrose solution and 0.5% proparacaine eye drops)
|
1 |
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
34.00 Day(s) |
| Gender |
Both |
| Details |
Neonates 30-34 weeks postmenstrual age undergoing screening for retinopathy of prematurity
|
|
| ExclusionCriteria |
| Details |
1. Infant receiving sedation or analgesic medications for any reason.
2. Infants on mechanical ventilation.
3. Any congenital malformations, or neurological dysfunction.
4. Parents refusing consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. PIPP score (Premature infant pain profile) during screening for retinopathy of prematurity |
1. PIPP score (Premature infant pain profile) during screening for retinopathy of prematurity |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. PIPP score during screening for retinopathy of prematurity
2. PIPP score post laser :time point 1,5,10 minutes post procedure
3. Heart rate at speculum insertion, during procedure, post procedure: time point 1,5,10 minutes.
4. Respiratory rate at speculum insertion, during procedure, post procedure :time point 1,5,10 minutes .
5. Apnea (during and 2 hrs post procedure)
6. Median duration of laser therapy.
7. Crying time post laser.
8. Incidence of Chest wall rigidity.
|
1,5,10 minutes |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/01/2018 |
| Date of Study Completion (India) |
16/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
Modification(s)
|
Standard pain relief measures used in neonates such as oral sucrose, oral paracetamol, proparacaine eye drops, EBM, non nutritive sucking , swaddling, KMC etc may be inadequate in relieving pain associated with screening for ROP. Intranasal fentanyl is a standard analgesic used in children for severe pain. We hypothesized that administration of fentanyl intranasally in addition to standard pain relief would result in a further 50 % reduction in Pain score (PIPP)in premature neonates undergoing ROP screening . 56 patients would need to be recruited for a study power of 90% and two tailed alpha of 0.05.
|