Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- PIPP score
研究概览
简要总结
Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.
Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
详细描述
Aims: To evaluate the effects of topical Benoxinate HCL eye drops on Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.
Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A dedicated clinical pharmacist placed the topical benoxinate HCL (Benox ®, Removed for facilitating the blinded review). and the artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops (Polyfresh ®, Removed for facilitating the blinded review) in identical bottles, each of them had a code that was changed every clinic and was not known to the examining ophthalmologist, the nurse in charge of swaddling the baby and putting the drops or the attending neonatologist monitoring the infant and recording the PIPP score. The clinical pharmacist would ensure that crossover was performed in the second examination of every study child.
入排标准
- 年龄范围
- 28 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with GA ≤34 weeks and/or with birth weight ≤2000 g
- •Preterm infants with larger GA or birth weight who were at increased risk of ROP according to the attending neonatologist
- •Infants were believed to require at least 2 ROP screenings
排除标准
- •Infants on muscle relaxants, analgesics, sedatives, or exogenous steroids
- •Infants who required mechanical ventilation or continuous positive airway pressure at the first examination
研究组 & 干预措施
Tear substitute in first exam
Te first examination was done using the tear substitute eye drops and the second using the Benoxinate HCL drops given just before the ROP screening.
干预措施: artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops. (Drug)
Benoxinate HCL in first exam
infants in Group B had the reversed order of the drops in the two examinations. the first examination done using the Benoxinate HCL drops and the second using the tear substitute eye drops
干预措施: Benoxinate Hydrochloride (Drug)
结局指标
主要结局
PIPP score
时间窗: 1-3 month after birth
The PIPP is a composite measure that includes seven indicators, each of which is rated on a four-point scale (0-3). The indicators include heart rate, oxygen saturation, GA, brow bulge, nasolabial furrow, behavioural state, and eye squeeze. Larger number indicates more stress (worse outcome)
次要结局
未报告次要终点
研究者
Islam Shereen Hamdy
Associate Professor
Alexandria University