| CTRI Number |
CTRI/2024/11/076929 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Using a combination of nasal Fentanyl and Paracetamol (Pain control drug) works better to control pain than just Paracetamol (Pain control drug) alone in newborns getting regular eye check-up. |
|
Scientific Title of Study
|
Comparing the efficacy of Intranasal Fentanyl along with Paracetamol in reduction of pain to
Paracetamol alone in neonates undergoing ROP examination- A randomised 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 Pasupathi Raj B |
| Designation |
DM Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Neonatology
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9159527550 |
| Fax |
|
| Email |
pasupathi482@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Kumar Choudhary |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Neonatology,
AIIMS Jodhpur,
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9013355932 |
| Fax |
|
| Email |
drsusil85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Kumar Choudhary |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Neonatology,
AIIMS Jodhpur,
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9013355932 |
| Fax |
|
| Email |
drsusil85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS Jodhpur,
Rajasthan-342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pasupathi Raj |
AIIMS Jodhpur |
Department of Neonatology
Jodhpur
RAJASTHAN |
9159527550
pasupathi482@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P09||Abnormal findings on neonatal screening, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Fentanyl and Oral Paracetamol |
Oral Paracetamol:
The neonate will receive Oral Paracetamol Syrup (Paracet-S 5ml/125mg) at 15mg per kg of body weight, given 30 minutes before the procedure.
Interventional solution Preparation:
Fentanyl will be prepared at a concentration of 10 micrograms per milliliter by mixing 2 milliliters of the available fentanyl solution (50 micrograms per milliliter) with 8 milliliters of normal saline (0.9%). An extra 0.1 milliliters will be added to account for the dead space in the syringe.
Once prepared, the intervention solution will be loaded into a 1-milliliter syringe. The syringe will then be handed to the principal investigator, who will attach it to the mucosal atomization device (MAD) and prime the device with the solution. If necessary, the baby’s nasal passages will be suctioned to remove blockages before administering the medication.
Medication Administration:
The medication will be given at 2mcg/kg and split between both nostrils to improve absorption and reduce waste, with a maximum of 0.3 milliliters per nostril. After administration, the atomizer should be held in place for 5 to 10 seconds to absorb the medication.
The neonate will be positioned at a 45-degree angle with their head still. The atomizer will be placed gently against the nostril, aiming slightly upward and outward (toward the ear), forming a seal to prevent leakage. Five minutes before the scheduled ROP procedure, the principal investigator will push the syringe plunger to deliver half of the dose to one nostril and then immediately deliver the rest to the other. |
| Comparator Agent |
Intranasal Placebo (Normal saline) and Oral Paracetamol |
Oral Paracetamol:
The neonate will receive Paracet-S 5ml/125mg oral paracetamol syrup at 15mg/kg 30 minutes before the procedure.
Comparator Preparation:
The comparator (normal saline) will be prepared by mixing 2 ml of the solution with 8 ml of normal saline (0.9%). An extra 0.1ml will be added for the syringe’s dead space. After preparation, the solution will be loaded into a 1ml syringe and handed to the principal investigator. The investigator will attach the syringe to the mucosal atomization device (MAD) and prime it. If needed, the baby’s nasal passages will be suctioned before medication delivery.
Medication Administration:
The dose will be 2mcg/kg and split between both nostrils, with a maximum of 0.3ml per nostril. The atomizer will be placed for 5-10 seconds to allow absorption.
The neonate will be positioned at a 45-degree angle, with their head still. The atomizer will be placed gently against the nostril, aimed slightly upward and outward (toward the ear), forming a seal to prevent leakage. Five minutes before the ROP procedure, the principal investigator will deliver half the dose to one nostril and the rest to the other. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Day(s) |
| Age To |
5.00 Month(s) |
| Gender |
Both |
| Details |
All neonates admitted to the NICU fulfilling the criteria for ROP screening as per our unit protocol. |
|
| ExclusionCriteria |
| Details |
1. Neonates who received Paracetamol or Fentanyl or any analgesics in the last 48 hours for pain control
or sedation (Persistent pulmonary hypertension of the newborn) will be excluded.
2. Any malformation involving the nasal cavity, like choanal atresia, etc. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain reduction will be measured using the PIPP-R score for the first 30 seconds after the ROP screening procedure. |
Immediately for 30 seconds after the ROP screening procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the PIPP-R score in both groups |
After speculum insertion and 2minutes, 5 minutes post ROP screening |
To observe the increase or new onset of apnea, desaturation episodes, and their severity
|
48 hours following the ROP examination |
| To observe the occurrence of new-onset or exacerbation of feed intolerance |
48 hours
following the procedure |
| To observe the heart rate patterns and Blood Pressure |
Till 3 hours following the procedure |
| To evaluate the adverse effects profile of intranasal fentanyl |
48 hours
post-administration. |
| To assess the cardiorespiratory stability score |
48 hours post administration of intervention |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 3 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Retinopathy of Prematurity (ROP) screening is crucial for preventing blindness in premature infants. Still, the procedure can cause significant discomfort and pain due to bright lights, mydriatic drops, and physical manipulation of the eyes. This discomfort may lead to adverse clinical conditions, impacting the infants’ health and neurodevelopment. Despite various studies on pain management during ROP screening, effective solutions without significant adverse effects have not been consistently found. In response, we propose a novel approach combining intranasal fentanyl with oral paracetamol alongside standard care. We hypothesize that this combination will significantly reduce pain during the screening process. While prior research has indicated that intranasal fentanyl is safe and effective, there has been limited investigation into the synergistic effects of combining it with oral paracetamol in this context. This study aims to evaluate the efficacy and safety of this combined analgesic strategy, addressing a knowledge gap in current neonatal pain management practices. We hypothesize that administering both intranasal fentanyl and oral paracetamol will be more effective in alleviating pain than paracetamol alone during ROP screening. |