The Role of Time Interval Elimination on Pain Control of Preterm Infants by Sucrose Administration
Condition: Neonatal Disease; Pain, Acute
MeSH terms: Infant, Newborn, Diseases; Acute Pain
Study type: Interventional

Summary: 
      Purpose. It has been demonstrated clearly that sucrose solutions given before a minor painful
      procedure can reduce pain among newborns. But, there are no entirely accepted conclusions
      about the time scheduling of sucrose administration prior to heel lance. In a few studies,
      various time intervals between sucrose intake and heel lance procedure have been proposed.
      The aim of this study was to obtain a deeper knowledge of the underlying mechanism by
      investigating whether a different initiation of heel lance in terms of timing would reduce
      the effect of orally administered sucrose at heel lance among preterm newborns.

      Methods. A randomized, double-blind trial with a validated, neonatal, pain-scoring scale in
      Gulhane Medical School Hospital in Ankara, Turkey between March 2019 and January 2021. The
      trial included 69 preterm newborns undergoing heel lance, who were assigned randomly to 1 of
      2 groups, ie, group I, with the 2-minute-time interval of per oral 24% sucrose given prior to
      heel lance or group II, without a time interval of per oral sucrose given prior to heel
      lance. Pain-related behavior during blood sampling was measured with the Premature Infants
      Pain Profile-Revised (PIPP-R). Crying incidence, duration, and heart rate were also recorded.
      The aim of this study was to help to clarify the mechanism underlying the pain-reducing
      effect of orally administered sucrose by attempting to determine whether elimination of the
      time interval prior to heel lance would reduce the effect of oral sucrose among preterm
      newborns. Investigators hypothesized that there would be a significant difference in pain
      intensity without a waiting period after sucrose ingestion, measured at 30 and 60 s following
      heel lance using PIPP-R, and adverse events would be higher.
    

Detailed description: 
      The sample size was calculated based on the difference in the PIPP scores of the groups. A
      sample size of 54 (27 for each group) achieves 80% power to detect a large effect size of 0.8
      using a two-sided Mann-Whitney U test with a significance level of 0.05.

      After inclusion in the study, participating infants were randomized to one of two possible
      interventions during a clinically-required heel lance: 1) The 2-minute-time interval of per
      oral 24% sucrose given prior to heel lance (Group 1) or no time interval of per oral 24%
      sucrose given prior to heel lance (Group 2) combined with containment in a blanket while in
      an infant incubator. Enrollment and randomization into the 2-minute-time interval of per oral
      24% sucrose given prior to heel lance or no time interval of per oral 24% sucrose given prior
      to heel lance (within 10 s) interventions were carried out by a member of the research team
      using a computerized off-site password protected website. Intervention allocation concealment
      was achieved by using randomly permuted stratified randomization of gestational week and
      gender. The treatment allocations were inserted into identical sealed envelopes marked only
      with a number. Solutions of 24% sucrose were freshly prepared daily by pharmacy using 2.4 g
      sucrose plus 10 ml distilled water. Solutions were packaged in 1 ml sterile syringes and
      further packaged in opaque sealed envelopes labeled according to the randomization code. The
      research team including two clinicians and nurses were masked in the treatment allocation.
      Outcome assessor was also blinded.
    

Intervention name(s): 2-minute-time interval of per oral 24% sucrose; no time interval of per oral 24% sucrose
Intervention type(s): Procedure; Procedure
Intervention description(s): Experiment began with a five-minute observation period of all outcome measures while infant was resting in an incubator. Later, attendant nurse gave 1 ml of 24% sucrose solution on neonate's tongue. In the 2-two minute-time interval prior to heel lance intervention, following two minutes of waiting period, heel lance procedure was applied to infant's foot. In no time interval of sucrose given immediately prior to heel lance intervention, attendant nurse performed heel lance procedure immediately after giving 1 ml of 24% sucrose solution sucrose on tongue. Infant's facial actions and heart rate, and oxygen saturation were recorded by using two video cameras. Recording was carried out by a nurse during whole procedure. After collecting data, researcher watched videos separately and scored them by using PIPP-R. Measurement of study outcome relied on data collection strategies: Neonatal close-up video recording of infant facial actions, pulse oximeter, observation for adverse events.; no time interval of per oral 24% sucrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: preterm; pain; sucrose; dopamine