DEPARTMENT OF PEDIATRICS

ERA’S LUCKNOW MEDICAL COLLEGE AND HOSPITAL, LUCKNOW

THESIS PROTOCOL

Pain during orogastric tube insertion in low birth

weight neonates with or without Kangaroo
Mother Care: Open labelled Randomized Trial

M.D. PEDIATRICS
(ERA’S LUCKNOW MEDICAL COLLEGE & HOSPITAL,
LUCKNOW)

SUBMITTED FOR APPROVAL BY

DR. ANANTIKA GARG(MBBS)

POST GRADUATE STUDENT IN PAEDIATRICS (M.D)
DEPT. OF PEDIATRICS
SESSION (2018-2021)
To,
The Principal, Dean & CMS,
Era's Lucknow Medical College & Hospital,
Lucknow, Uttar Pradesh

THROUGH PROPER CHANNEL

Sub: Submission of thesis protocol for M.D. (Pediatrics).

Respected Sir,

I wish to have my thesis entitled “Pain during orogastric tube insertion in low birth
weight neonates with or without Kangaroo Mother Care: Open labelled Randomized Trial.”

Registered for M.D. (Pediatrics) examination of Era’s Lucknow Medical College and
Hospital, Lucknow to be held in year 2021. The necessary particulars and Proforma along with
recommendation of Guide are being submitted here with for necessary action.

Thanking you

Date: Yours sincerely

DR. ANANTIKA GARG

Junior Resident - I
Department of Pediatrics
ELMC&H, Lucknow

FORWARDED AND RECOMMENDED BY HOD

DR. (PROF). SHITANSHU SHRIVASTAVA
Professor, Head of Department
Department of Pediatrics,
Era's, Lucknow Medical College and Hospital, Lucknow.
 ERA’S LUCKNOW MEDICAL COLLEGE AND HOSPITAL,
LUCKNOW,UTTAR PRADESH

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR THESIS

1 NAME OF THE CANDIDATE
2 NAME OF THE INSTITUTION
3 COURSE OF STUDY AND
SUBJECT
4 4.1 MONTH AND YEAR OF
GRADUATION
4.2 COLLEGE FROM WHICH
GRADUATE
5 Pain during orogastric tube insertion
TITLE OF THE TOPIC
DR. ANANTIKA GARG
P.G. IN PAEDIATRICS,
ERA’S LUCKNOW MEDICAL COLLEGE
AND HOSPITAL, LUCKNOW, UTTAR
PRADESH.
ERA’S LUCKNOW MEDICAL COLLEGE
AND HOSPITAL, LUCKNOW
M.D. IN PAEDIATRICS
JANUARY,2017
D.Y. PATIL SCHOOL OF MEDICINE,
NAVI MUMBAI
in low birth weight neonates with or
without Kangaroo Mother Care: Open
labeled Randomized Trial

6 BRIEF RESUME OF INTENDED APPENDIX-I

WORK
6.1 INTRODUCTION APPENDIX-IA
6.2 RESEARCH QUESTION AND APPENDIX-IB
HYPOTHESIS
6.3 REVIEW OF LITERATURE APPENDIX-1C
6.4 OBJECTIVES OF THE STUDY APPENDIX-1D
7 MATERIALS AND METHODS APPENDIX-II
6.1 SOURCE OF DATA APPENDIX-IIA
6.2 METHOD OF COLLECTION APPENDIX-IIB
OF DATA :
6.3 WORK UP PLAN APPENDIX-IIC
7.4 DOES THE STUDY
REQUIRE ANY YES
INVESTIGATION OR APPENDIX-IID
INTERVENTIONS
TO BE CONDUCTED ON
PATIENTS OR
OTHER ANIMALS.
7.5 HAS ETHICAL CLEARENCE APPENDIX-IIE
BEEN
 OBTAINED FROM YOUR
INSTITUTION IN CASE OF 7.4
8 LIST OF REFERENCES APPENDIX – III

9 SIGNATURE OF THE
CANDIDATE
REMARKS OF THE GUIDE

11 NAME AND DESIGNATION

11.1 GUIDE Dr. Geetika Srivastava

MD (Paediatrics)
Associate Professor
Department Of Pediatrics,
ELMCH, Lucknow

11.2 SIGNATURE

Dr. (Prof.) M.M.A Faridi

11.1 CO-GUIDE (MD,DCH,MNAMS,FIAP,FNNP)
Principal, Dean & Chief Medical
Superintendent
Professor of Pediatrics
Era’s Lucknow Medical College &
Hospital, Lucknow

11.2 SIGNATURE

11.3 CO-GUIDE Dr. Chhavi Nanda

DCH, DNB (Paediatrics)
Assistant Professor
Department of Pediatrics
Era’s Lucknow Medical College &
Hospital, Lucknow

11.4 SIGNATURE
 APPENDIX-I

6. BRIEF RESUME OF THE INTENDED WORK:

APPENDIX-I A

6.1 INTRODUCTION
Pain is subjective phenomenon and is defined as an unpleasant sensory and emotional response
produced by potential or actual tissue damage.[1]Pain pathways are formed well before birth, so a human
foetus is able to perceive nociceptive stimuli even before 30 weeks of gestation.[2]

According to the guideline published by the Royal Australian College of Physician(RACP), the
most commonly used pharmacological methods for the management of procedural pain in newborns are
opiods, hynosedatives and N-methyl-D-aspartic acid(NMDA) receptor antagonist.[4] Pharmacological
methods used to relieve pain in newborns are reported have side effects such as respiratory depression,
apnea, bradycardia, hypotension, desaturation, partial airway obstruction and hypersalivation.[3,4]

Neonates in NICU are usually exposed to painful procedures, without receiving appropriate pain
medication. Various painful procedures a neonate might undergo during stay in NICU includes heel prick,
venepuncture, NG tube insertion, lumbar puncture, suctioning, catheterisation and intubation.[5]
79% of these procedures are done without analgesia.[5] According to a study, analgesia was offered to
only 23% of neonates undergoing gastric tube insertion.[5] Exposure to prolonged or severe pain causes
increased stress in neonates with immediate physiological effects like increased oxygen consumption,
decreased nutrient intake, altered sleep and wakefulness while in long term these babies are more prone to
adverse neurodevelopment outcome and altered response to subsequent painful stimuli.[6-9]

The various non-pharmacological measures for pain relief include Kangaroo mother care, tactile
soothing, swaddling and oral dextrose solution in different strength and the pharmacological measures
include paracetamol and opioid boluses or infusion.[11,12]

Kangaroo mother care is the early, continuous and prolonged skin-to-skin contact between the
mother and baby that includes exclusive breast feeding(ideally) and is initiated in hospital and continued
at home.[13]

The length of skin-to-skin contact should be atleast 60minutes, gradually increasing to become as
continuous as possible, day and night, interrupted only for changing diapers.[13] KMC tends to be used
until the baby reaches term(post conception 40 weeks) or 2500g.[13]
 APPENDIX IB

6.2 RESEARCH QUESTION

Does kangaroo mother care reduce pain on insertion of orogastric tube in low birth weight neonates ?
 APPENDIX –IC

REVIEW OF LITRATURE

Year Study Sample Conclusion

Size

Bhandeka 2018 Effectiveness of 80 KMC is an effective non

r et al Kangaroo mother pharmacological and safe
care in reducing modality in reducing pain in
pain during premature neonates during
minor procedures minor painful procedure like
in preterm venepuncture as compared
neonates to conventional care

Mahmud 2017 Neonatal pain and 252 Oral dextrose is a cheap and
et al preventive easily available solution and
strategies: An can be used in neonatal pain
experience in a management during various
tertiary care unit painful procedure

Johnston 2017(cochr Skin to skin care 25 Kangaroo care appear to

C et al ane for procedural reduce the pain response to
Database of pain in and recovery from frequent
systemic neonate(review) procedures
review)

Ravishan 2014 Oral dextrose for 150 Oral D25 was effective in
kar, analgesia in reducing the pain response
Thawani neonates during during NGT insertion in
et al nasogastric tube neonates when compared
insertion: A RCT with oral D10 and placebo.
Nanavati 2013 Effect of KMC 50 Removal of tape is a painful
et al v/s EBM procedure in VLBW. There
administration on is no difference between
pain associated KMC and EBF in relieving
with removal of pain.
adhesive tape in
VLBW:A RCT
2012 Reduction of 104 Lingual sucrose 25% is an
Nimbalka neonatal pain effective analgesic for
r et al following relieving pain during
administration of orogastric tube insertion.
25% lingual
dextrose
 APPENDIX-1D

6.4 AIMS AND OBJECTIVES OF STUDY

AIM
To study the effect of KMC in reducing pain during orogastric tube insertion in low birth weight neonates.

OBJECTIVES

1] Primary Objective –

Proportion of neonates exhibiting moderate to severe pain according to the Premature Infant pain
profile(PIPP) scale with or without KMC.

2] Secondary Objective – To observe adverse effects of orogastric tube insertion in the above
patients including

• Bradycardia (Heart rate <100bpm)

• Desaturation (SpO₂ <93% in term neonates and <85% in preterm neonates)

• Apnoea (absence of spontaneous respiration for more than 20 seconds or any duration if
accompanied with bradycardia or cyanosis)
 APPENDIX-II

7.0 MATERIALS AND METHODS

APPENDIX-II A

7.1 SOURCE OF DATA: The study will be conducted in the NICU of Department of Pediatrics at Era’s

Lucknow Medical College and Hospital, Lucknow.

METHODS AND MATERIAL

Study Design: Open Labelled Randomised trial

Place of study: Department of Paediatrics and Neonatology, Era’s Lucknow Medical College and
Hospital, Lucknow

Study Period: 24 months between October 2018 and December 2020

Sample size: 80(40 in each group)

 STATISTICAL ANALYSIS

Sample size is calculated from the study “Reduction of neonatal pain following administration of 25%
lingual dextrose: A Randomised control Trial”.[14]

It is calculated on the basis of proportion of PIPP score (>7) among the two group using the formula:

N= [ Zά√2p(1-p) + Zβ√p₁(1-p₁) + p₂(1-p₂) ]² / (p₁-p₂)²

where p₁= 0.02(2%)

p₂= 0.288(28.8%) the proportion of PIPP score (>7) in the two groups

 Type I error ά =5%

 Type II error β =20% for detecting results with 80% power of study

 Data loss =10%

The sample size comes out to be n=40 each group

 APPENDIX-II A

7.2 METHOD OF COLLECTION OF DATA

After obtaining informed written consent from patient’s parents, they will be clinically evaluated.

INCLUSION CRITERIA
• All Haemodynamically stable (off mechanical ventilation and ionotropes) low birth weight
neonates.
• Having birth weight of 1500-2499g
• Admitted to NICU

EXCLUSION CRITERIA
• APGAR <3
• Recurrent apnoea
• Gross congenital anomalies
• Neonates who received analgesia/sedative 24hrs before inclusion
 PROCEDURE
1. After obtaining approval from the institutional ethical committee and written and informed consent
from the parents, neonates will be recruited for the study.

2. In this study, 80 low birth weight neonates i.e.1500-2499g which are haemodynamically stable(off
mechanical ventilation and ionotropes) admitted to NICU of Era’s Lucknow medical college and
Hospital, Lucknow will be enrolled.

3. Neonates will be divided into 2 groups according to sequentially numbered opaque sealed
envelope(SNOSE) technique and block randomization of 2:2 will be done to avoid bias (40 in each
group).

4. Neonates with APGAR <3, recurrent apnea, gross congenital anomalies, and those who received
sedatives or analgesic 24 hrs before procedure will be excluded.

5. The Baseline behavioral state will be scored of all the Low birth weight neonates (ie 1500-2499g)
in both the study as well as control group, one minute prior to the procedure for 30 seconds using
PIPP scoring.

6. We will note the gestational age, baseline heart rate and oxygen saturation at the beginning of the
shift. Observe the infant for 30 seconds.
7. After clinical assessment, a size of 6-8F orogastric tube will be inserted in the mouth after
estimating the desired length by measuring the distance from the nasal alae to the helix and the
helix to the xiphisternum.

8. Neonates in the study group will receive Kangaroo mother care for 60 minutes uninterrupted prior
and through out the procedure and for atleast 60 minutes after orogastric tube insertion.

9. Neonates in the control group will be put in cradle with a radiant warmer in servo-controlled
mode(skin temperature 36.5⁰C),1hour before and after orogastric tube insertion. The neonate is
inclined at 45⁰ while putting the tube so at to maintain the same position as the study group.

10. No lubricant will be used in the procedure.

11. The maximum heart rate and minimum saturation from the time of orogastric tube insertion until
15 min after the insertion using a vital sign monitor.

12. The other observer will videotape the entire procedure and the infants response using a 5megapixel
video camera at 720p resolution.

13. The videos will be saved in a computer, and quantification of pain will be done using the PIPP
score subsequently by a blinded observer.

14. PIPP scoring will be done during orogastric tube insertion, air test for correct placement of the
tube, at 3min and after 15min of orogastric tube insertion.
 APPENDIX-IIC

7.3 WORKUP PLAN

Premature Infant Pain Profile (PIPP) [15]

[Ref]: Stevens B, Johnson C, Petryshen P, Taddio A:

Premature infant pain profile: Development and initial
evaluation. Clin J Pain 12:13-22,1996.
 APPENDIX-II D

7.4 Does the study require any investigation or intervention to be conducted on the patients or

animals, if so please describe briefly

NA
 APPENDIX-IIE
PROFORMA APPLICATION FOR ETHICS
COMMITTEE APPROVAL
SECTION A

PAIN DURING OROGASTRIC TUBE INSERTION

A IN LOW BIRTH NEONATES WITH OR WITHOUT
Title of the study
KANGAROO MOTHER CARE: OPEN LABELLED
RANDOMIZED TRIAL

DR. ANANTIKA GARG

P.G. IN PEDIATRICS,
B Principle investigator
ERA’S LUCKNOW MEDICAL COLLEGE AND
(Name and Designation)
HOSPITAL, LUCKNOW, UTTAR PRADESH.

DR. GEETIKA SRIVASTAVA,

MD (PAEDIATRICS)
C Co-investigator
ASSOCIATE PROFESSOR
(Name and Designation)
DEPARTMENT OF PEDIATRICS,
ELMCH,LUCKNOW

D Name of the Collaborating

NO
Department/Institutions
Whether permission has been obtained from
E
the heads of the collaborating departments & NA
Institution
Section – B
APPENDIX – II
Summary of the Project
Section – C
APPENDIX – IC
Objectives of the study
Section – D
APPENDIX – IIB
Methodology
A Where the proposed study will be undertaken ELMC & HOSPITAL, LUCKNOW
B Duration of the Project 24 MONTHS
C Nature of the subjects:
Does the study involve adult patients? NO
Does the study involve Children? YES
Does the study involve normal volunteers? NO
Does the study involve Psychiatric patients? NO
Does the study involve pregnant women? yES

D If the study involves health volunteers

I.Will they be institute students? NO
II.Will they be institute employees? NO
 III.Will they be paid? NA
IV.If they are to be paid, how much per NA
session?
E Is the study a part of multi central trial? NO

F If yes, who is the coordinator?

(Name and Designation) NA

Has the trail been approved by the ethics NA

Committee of the other centers?

If the study involves the use of drugs please NA

indicate whether.

I. The drug is marketed in India for the NA

indication in which it will be used in the
study.

II. The drug is marketed in India but not for NA

the indication in which it will be used in the
study

III. The drug is only used for experimental NA

use in humans.

IV. Clearance of the drugs controller of India NA

has been obtained for:

Use of the drug in healthy volunteers

Use of the drug in-patients for a new NA
indication.
Phase one and two clinical trials
Experimental use in-patients and
healthy volunteers.
G How do you propose to obtain the drug to
be used in the study?
-Gift from a drug company
NA
-Hospital supplies
-Patients will be asked to purchase
-Other sources (Explain)
H Funding (If any) for the project please
state
-None
NONE
-Amount
-Source
-To whom payable
 Does any agency have a vested
I interest in the outcome of the NO
Project?
Will data relating to subjects
J /controls be stored in a computer? YES

Will the data analysis be done by

K -The researcher YES
-The funding agent NO
L Will technical / nursing help be
required form the staff of hospital. NO

If yes, will it interfere with their NO

duties?

Will you recruit other staff for the NO

duration of the study?

If Yes give details of

-Designation
-Qualification
-Number
-Duration of Employment NA
M Will informed consent be taken? If YES
yes
Will it be written informed consent:
YES
Will it be oral consent?
Will it be taken from the subject NO
themselves? YES
Will it be from the legal guardian?
YES
If no, give reason:
NA
N Describe design, Methodology and APPENDIX II
techniques
Ethical clearance has been accorded.

Chairman,
P.G Training Cum-Research Institute,
ELMC & HOSPITAL, LUCKNOW.
Date:

PS: NA – Not Applicable

 APPENDIX-IID

DEPARTMENT OF PEDIATRICS
ERA’S LUCKNOW MEDICAL COLLEGE AND HOSPITAL,
LUCKNOW

WORKING PERFORMA

 CASE NO:
 OPD/IPD NO:
 DATE:
 NAME:
 AGE:
 SEX:
 ADDRESS:
 RURAL/URBAN:
 MODE OF DELIVERY:
 LMP: EDD:
 GESTATION AGE BY DATE:
 GESTATION AGE BY BALLARD SCORE:

ANTHROPOMETRY
 WEIGHT:
 LENGTH:
 HEAD CIRCUMFERENCE:
 CHEST CIRCUMFERENCE:
 PONDERAL INDEX:
GENERAL EXAMINATION
 PULSE RATE:
 RESPIRATORY RATE:
 TEMPERATURE:
 SPO2:
 PALLOR:
 ICTERUS:
 CYNOSIS:
 APGAR SCORE AT 1MIN,5MIN,10MIN:
 DURATION OF CRY:

SYSTEMIC EXAMINATION
 P/A:

 RS:

 CVS:

 CNS:

INDICATION FOR PUTTING OROGASTRIC TUBE:

 TIME 1 MIN DURING DURING AFTE AFTER
PRIOR INSERTI AIR R3 15 MINS
ON TEST MINS
PROCESS INDICATOR

GESTATIO
CHART
N AGE
Active, awake, 0
eyes open, facial
movements
Quiet, awake, 1
eyes open, no
OBSERVE
facial movement
INFANT BEHAVIOR
Active, awake, 2
FOR AL STATE
eyes closed,
15SECS
facial movement
Quiet, asleep, 3
eyes closed,
no facial
movement
OBSERVE HEART
BASELIN RATE
E HR MAXIMUM
AND O2
SATURA O2
TION SATURATI
FOR 30 ON
SECS
0
None
1
BROW Minimum
BULGE 2
Moderate
3
Maximum
OBSERVE 0
None
INFANT 1
FACIAL Minimum
ACTIONS EYE 2
FOR 30 SQUEEZE Moderate
SECS 3
Maximum
0
None
1
NASIO Minimum
LABIAL 2
Moderate
FURROW 3
Maximum
 APPENDIX-III

8. LIST OF REFERENCES

1. Nimbalkar SM, Chaudhary NS, Gadhavi KV, Phatak A. Kangaroo mother Care in reducing
pain in preterm neonates on heel prick. Indian J Pediatric 2013;80(1):6-10.

2. Lowery CL Hardman MP, Manning N, Hall RW, Anand KJS. Neurodevelopment changes of
fetal pain. Semin Pernatol.2007;31(5):275-82.

3. TwycrossA. Why managing pain in children matters. In: Twycross SJ, Dowden E, Bruce
(Eds.). Managing pain in children. United Kingdom: Wiley- Blackwell;2009,PP1-15

4. Walter-Nicolet, Annequin D, Biran V, Mitanchez, D, Tourniaire B. Pain in newborns from

prevention to treatment. Pediatr Drugs 2010;12:353-65.

5. Carbajal R, Rousset A, Danan C et al. Epidemiology and treatment of painful procedures

in neonates in intensive care units. JAMA 2008;300:60-70.

6. Anand KJ, McIntosh N, Lagercrantz H, Pelausa E, Young TE, Vasa R. Analgesic and
sedation in preterm neonates who require ventilatory support :results from the Neonatal
Outcome and Prolonged Analgesia in Neonatal trial. Arch Pediatr Adolesc
Med.1999;153:331-38.

7. Grunau RE. Neonatal pain in very preterm infants: long-term effects on brain,
neurodevelopment and pain reactivity. Rambam Maimonides Med J. 2013;4(4):e2005.

8. Walker SM, Franck LS, Fitzgerald M, Myles J, Stocks J, Marlow N. Long-term impact of
neonatal intensive care and surgery on somatosensory perception in children born
extremely preterm. Pain. 2009;141:79-87.

9. Bellieni CV, Lantorno L, Perrone S, Rodriguez A, Longini M,Capitani S, et al. Even routine
painful procedures can be harmful for the newborn. Pain. 2009;147:128-31.T

10. Krishnan L. Pain Relief in Neonates. J Neonatal Surg 2013;2(2):19

11. Iqbal AM, Malik RA, Siddique MU, YuqubM IT, Farrukh H, Waqar T.Breastfeeding for pain
relief during bacillus Calmette-Guerin(BCG) vaccination in term neonates. Pak J Med
Health Sci 2014;8(2):403-6.

12. Bellieni CV, Stazzoni G, Tei M, Alagna MG, Iacoponi F, Cornacchione S, et al. How painful
is a heelprick or a venepuncture in a newborn? J Matern Fetal Neonatal Med
2016;29(2):202-6.

13. World Health Organisation. Kangaroo Mother Care: a practical guide. Department of
Reproductive Health, WHO, Geneva. 2003:7-46. Available from
http://apps.who.int/iris/bitstream/10665/42587/1/9241590351.pdf

14. Nimbalkar S, Sinojia A, Dongara A. Reduction of Neonatal Pain following

administration of 25% Lingual Dexrose. Journal of Tropical Pediatrics December 21,2012.

15. Stevens B, Johnson C, Petryshen P, Taddio A: Premature infant pain profile: Development
and initial evaluation. Clin J Pain 12:13-22,1996.