研究目的
To compare the efficacy of low dose fentanyl infusion and 24% oral sucrose in providing optimal pain relief during laser treatment for retinopathy of prematurity (ROP).
研究成果
Low dose (1 mcg/kg/hour) fentanyl infusion was found to be effective in reducing pain and also safe during laser treatment for ROP in spontaneously breathing preterm infants.
研究不足
Blinding could not be done due to the nature of the intervention. Many preterm infants were excluded due to lack of bed in the neonatal intensive care unit. The study population was heterogeneous with respect to post-menstrual age and weight. Salivary cortisol could be collected in only 53% of all enrolled preterm infants.
1：Experimental Design and Method Selection:
Open label parallel randomized clinical trial comparing low dose fentanyl infusion (1 mcg/kg/hr) with 24% oral sucrose (2 ml) during laser for ROP in spontaneously breathing preterm infants.
2：Sample Selection and Data Sources:
Fifty-eight spontaneously breathing preterm infants undergoing laser therapy for ROP were enrolled.
3：List of Experimental Equipment and Materials:
Injection fentanyl (Verve Health Care Ltd., New Delhi), 24% sucrose (Ocular pharmacy, Dr Rajender Prasad Center for Ophthalmic Sciences, AIIMS, New Delhi), portable voice recorders, digital-camera, Salivette (Starstedt, Germany).
4：Experimental Procedures and Operational Workflow:
Infants were randomized to receive either fentanyl infusion or 24% oral sucrose. Outcomes measured included proportion of time spent crying, salivary cortisol levels, PIPP-R scores, and complications.
5：Data Analysis Methods:
Statistical analysis was done using Stata 11.2. Categorical variables were compared by chi square/Fisher’s exact test. Continuous variables were compared by Student’s t test or Wilcoxson rank-sum test. GEE was used for multiple sequential recordings of PIPP-R.
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