Sucrose to Reduce Pain During Initiation of Venipuncture in Extremely Low Birth Weight Babies

Research Question

• Is 0.2 ml of 12% oral sucrose not inferior to 0.2 ml of 24% oral sucrose in reducing pain during initiation of venepuncture in extremely low birth weight infants?

Research Hypothesis

• 0.2 ml of 12% oral sucrose is not inferior to 0.2 ml of 24% oral sucrose in reducing pain during initiation of venepuncture in extremely low birth weight infants.

Aims and Objective

1. To study the effect of 0.2ml of 12% \& 24% oral sucrose on reducing the pain during initiation of venipuncture in Extremely Low Birth Weight (ELBW) infants.
2. To study the side effects associated with the administration of both the drugs.

Participant:

The study was conducted in the neonatal unit of Kalawati Saran Children's Hospital and Lady Hardinge Medical College, New Delhi. All the patients admitted in the neonatal units satisfying the inclusion criteria and not having any exclusion criteria were enrolled in the study.

Inclusion criteria:

• All extremely low birth weight babies (<1000gm) regardless of gestational age being admitted in NICU.
• Within first 48 hrs of post natal life
• Parental consent

Exclusion criteria:

• Neonates requiring ventilatory support.
• Neonates with any neurological impairment (HIE, seizures)
• Receiving opiates or born to mothers receiving opiates
• Newborns who have received muscle relaxants ,sedatives,analgesics
• Major congenital anomalies
• 5 mins Apgar of less than 7
• Neonates undergoing any surgery
• Birth trauma(especially precipitate deliveries)
• Instrumental delivery

Intervention

24%sucrose was prepared by mixing 2.4gm of sucrose in 10ml distilled water and 12%sucrose was prepared by mixing 1.2 gm of sucrose in 10 ml of distilled water. Out of these solutions 1ml was measured by 1 ml syringe and packed and covered with serially numbered opaque sealed envelopes. The composition of these packets were decided by a senior consultant in the department of pharmacology who had the access to the randomization sequence \& was uninvolved in the study. Fresh solutions were prepared daily and unused solutions were discarded at the end of the day to be replaced with identically numbered solutions from the laboratory. All study solutions were stored in the refrigerator at 2-8°C until they were used. The patient were enrolled into the study only after an informed written consent was obtained from either of the parent / care giver. At the initiation of venepuncture 2 min prior to procedure 0.2 ml of solution marked with patient serial no was administered by a prefilled syringe to the patient on the anterior aspect of the tongue avoiding spillage, by the personnel carrying out the procedure. The above mentioned personnel was blinded to the contents of the solution.

The procedure involved putting first cannula in vein of the dorsum of right hand. Gentle steady pressure applied with the thumb to make the chosen vein prominent while the remaining fingers of the same hand helping stabilize the hand.A 24 gauge needle was inserted into vein after asepsis 2 min after the neonate had been given the allocated oral solution.The needle was inserted into vein to obtain steady blood flow.The procedure was divided into three phases. The pre-procedure phase from the beginning of the recording to just short of needle insertion. The intra-procedure phase from needle insertion to needle removal and the post-procedure phase from needle removal to end of recording lasting upto 4 min. Video recording was done by a video camera focusing on face of the patient. Neonates were monitored using a non invasive vital signs monitor to monitor their heart rate .The second video camera was focussed on the non invasive vital signs monitor.Video recording started just before oral sucrose administration and continued till 4 min after the skin puncture.All stages of needle insertion were indicated on camera by the person performing the procedure. All video recordings were evaluated independently by a consultant of the unit, who was uninvolved in the study and was blinded to the study methodology. NFCS (Neonatal facial coding system) was used to evaluate pain.The entire process involved only a single attempt at venepuncture initiation and the same was ensured rigorously during the entire study.

Sample size calculation

As there were no preliminary trials in a population of ELBW neonates comparing 12% vs 24% sucrose a convenience sample of 30 \& 30 in each limb was taken.

Randomization:

Sequence Generation: Block randomization using computer generated random sequences was used with a block size of six each.

Allocation Concealment: This was done by the pharmacy which packed the 12% sucrose and the 24% sucrose into identical containers and opaque sealed envelopes sequentially labeled according to randomization code available with the consultant of Department of Pharmacology unrelated to the study.

Implementation: Randomization sequence was generated by a senior consultant in the Department of Pharmacology, unrelated to the study. The participants were enrolled for the study by the candidate according to the serial number and the candidate was blinded to the randomization code.

Blinding: The participants, the research candidate as well as the investigator assessing the painful response were blinded to the group assignment .Randomization codes and allocation sequences were broken only after the data analysis was finished.

Statistical Methods: The data was analyzed using Strata (version 11.2). Descriptive statistics (Mean, SD), Median (Range) were calculated. For comparison of Means between different groups unpaired students's t test was used. For analysis of categorical data chi-square test was used. Continuous data was also analyzed using non-parametric Ranksum (Mann-Whitney) test. Statistical significance was assumed at a P value of <0.05.