Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates
Condition: Pain in Preterm Neonates
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RESEARCH HYPOTHESIS Orally administered sucrose 2 minutes prior to the procedure of OGT
      insertion reduces pain associated with the procedure.

      AIMS AND OBJECTIVES:

      To study the effect of 24% oral sucrose on decreasing the painful response to orogastric tube
      insertion .
    

Detailed description: 
      MATERIAL & METHODS

      PARTICPANTS:

      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 (</=168 hours).

        -  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.

      INTERVENTIONS:

      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.

      OUTCOMES:

      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.

      SEQUENCE GENERATION:

      Block randomization using computer generated random sequences will be used.

      ALLOCATION CONCEALMENT:

      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.

      IMPLEMENTATION:

      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.

      BLINDING:

      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.
    

Intervention name(s): Sucrose; Double distilled water
Intervention type(s): Drug; Drug
Intervention description(s): 1 ml of 24% sucrose was administered 2 minutes prior to the procedure; 1 ml of double distilled water (Placebo) was administered 2 minutes prior to the procedure
Other intervention name(s): 24%Sucrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sucrose; pain; neonate; preterm; orogastric tube