Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates

2014-07-23 21:13:47 | BioPortfolio


RESEARCH HYPOTHESIS Orally administered sucrose 2 minutes prior to the procedure of OGT insertion reduces pain associated with the procedure.


To study the effect of 24% oral sucrose on decreasing the painful response to orogastric tube insertion .




INCLUSION CRITERIA: The enrolled participants must fulfill the following inclusion criteria:

- All pre-terms ( < 37 weeks of gestational age.)

- Within the first 7 days postnatal days (

- Clinically stable from respiratory, hemodynamic and metabolic point of view.

- Who have not received any painful stimulus at least 30 minutes prior to the intervention.

- Requiring routine orogastric tube insertion within the first 7 days of life.

- Only the first attempt at putting OGT in controlled NICU environment will be considered

EXCLUSION CRITERIA: The neonates with the following characteristics will be excluded from the study:

- Neonates requiring ventilatory support.

- Neonates requiring oxygen supplementation.

- Having any facial congenital anomalies.

- Having any neurological impairment.

- Receiving opiates or born to mothers receiving opiates.

- New born babies to whom muscle relaxants, sedatives and analgesics have been administered.

- With grade 3 and 4 IVH.

- With major congenital anomalies

- Any history of birth trauma especially involving face or scalp (including cephalhematoma/ subgaleal bleed).

- Face presentation.


There will be two groups in the study ( group A & group B). The enrolled neonates will be administered either a sterile solution of 24% sucrose or double distilled water orally. These solutions will be prepared under all sterile precautions by the laboratory staff unrelated to the study, and packed in 2 ml sterile syringes further covered with opaque sealed envelopes bearing serially numbered patient codes. The composition of these packets would be decided by a senior consultant in the department of pharmacology who would have the access to the randomization sequence and would be uninvolved in the present study. Fresh solutions will be prepared daily and unused solutions will be discarded at the end of the day to be replaced with identically numbered solutions from the laboratory. All study solutions will be stored in the refrigerator at 2-8 0C until they are used.

The patients will be enrolled into the study only after an informed written consent has been obtained from either of the parent/ caregiver. 2 minutes prior to procedure, 1 ml of the solution marked with patients's serial number will be administered orally to the patient by a nurse using the syringe. The procedure would involve putting a 5-6 Fr. OGT in the neonate which will be done by a group of 8-10 nurses who have been specially trained in this procedure. This insertion of OGT will be done 2 min post administration of test solution by a nurse who will be blinded to the contents of the solution.

The whole procedure (beginning 2 minutes before the OGT insertion and continuing till 4 minutes after it is inserted) will be video recorded on a fixed camera focusing on the face of the patient. Neonate will be monitored using a non invasive vital signs monitor to monitor his heart rate and SpO2 changes during the entire procedure and for 2 minutes post procedure. The highest heart rate and lowest SpO2 obtained during the procedure till 2 minutes post procedure will be recorded. The research candidate will evaluate the pain response to the procedure according to the PIPP scale at time t=pre-procedure, t=intra-procedure,t=post 30 sec, t=post 1min, & t=post 2 min; wherein t denotes the time at which tube is inserted into the oral cavity. The research candidate will also monitor the time taken in the OGT insertion using a stopwatch. The neonatal nurse putting the OGT will rate the procedure as easy, difficult or very difficult.


PRIMARY OUTCOME: Painful response, as assessed by the PIPP scale. SECONDARY OUTCOME: Maximum heart rate and minimum oxygen saturation recorded during the procedure.

SAMPLE SIZE CALCULATION:The sample size was calculated based on the assumption that there would be a decrease of at least 20% in the pain scores in the study population with the intervention and using a alpha error of 0.05 and a power of 90% the sample size was calculated to be 55 each in both the groups ie a total of 110 neonates.

RANDOMISATION:Block Randomisation using computer generated random sequences with a block size of 4 each.


Block randomization using computer generated random sequences will be used.


This will be done by the pharmacy who will pack the sucrose and the double distilled water (control/placebo) into identical containers and opaque sealed envelopes sequentially labeled according to randomization code.


Randomization sequence will be generated by a senior consultant in the department of pharmacology .The participants will be enrolled for the study by the candidate according to the serial number as the candidate will be blinded.


The participants, the research candidate,the nursing staff administering the intervention as well as the investigators assessing the painful response will be blinded to the group assignment

STATISTICAL METHODS: Descriptive statistics will be calculated.Between groups comparison of continuous variables will be done with the help of t test for parametric data and by Mann Whitney test for non parametric data.The proportion and frequencies will be calculated using the chi square test.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Pain in Preterm Neonates


Sucrose, Double distilled water


Lady Hardinge Medical College
New Delhi




Lady Hardinge Medical College

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:13:47-0400

Clinical Trials [1950 Associated Clinical Trials listed on BioPortfolio]

Sucrose Practices for Pain in Neonates

Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reduci...

Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates. The objective is to test this hypothesis in a randomized, contr...

Pain Reactivity to Non-Pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit

Switzerland is having one of the highest premature rates in Europa and most of the preterm neonates need neonatal intensive care. Up to 80% of the analgesic used in neonatal intensive care...

Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening

Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Un...

Sucrose Practices for Pain in Neonates Part B

Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reduci...

PubMed Articles [13881 Associated PubMed Articles listed on BioPortfolio]

Randomised crossover trial showed that using breast milk or sucrose provided the same analgesic effect in preterm infants of at least 28 weeks.

Repeated, on-going exposure to pain influences the growth, cognitive and motor functions, behaviour, personality and neurodevelopment of preterm infants. We compared the analgesic effects of expressed...

Trial of Music, Sucrose, and Combination Therapy for Pain Relief during Heel Prick Procedures in Neonates.

To compare the effectiveness of music, oral sucrose, and combination therapy for pain relief in neonates undergoing a heel prick procedure.

A Comparison of Breast Milk and Sucrose in Reducing Neonatal Pain During Eye Exam for Retinopathy of Prematurity.

This double-blind randomized controlled experimental study aimed to determine the effects of breast milk and sucrose in reducing pain in preterm infants during retinopathy of prematurity (ROP) examina...

Neutrophil chemotaxis and transcriptomics in term and preterm neonates.

Neutrophils play a crucial role in combating life-threatening bacterial infections in neonates. Previous studies investigating neonatal cell function have been limited because of restricted volume sam...

A longitudinal randomized trial of the impact of consistent pain management for infant vaccinations on future vaccination distress.

The objective was to determine if consistent pain management during vaccine injections has a beneficial effect on future infant pain reactivity. This was a multicentre, longitudinal, double-blind, dou...

Medical and Biotech [MESH] Definitions

Substances capable of increasing BODY TEMPERATURE and cause FEVER and may be used for FEVER THERAPY. They may be of microbial origin, often POLYSACCHARIDES, and may contaminate distilled water.

Sucrose present in the diet. It is added to food and drinks as a sweetener.

Chemicals used mainly to disinfect root canals after pulpectomy and before obturation. The major ones are camphorated monochlorophenol, EDTA, formocresol, hydrogen peroxide, metacresylacetate, and sodium hypochlorite. Root canal irrigants include also rinsing solutions of distilled water, sodium chloride, etc.

A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.

Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.

More From BioPortfolio on "Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates"

Quick Search

Relevant Topics

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Searches Linking to this Trial