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Status unknownNCT01872871Updated Jun 7, 2013

The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial

An interventional study of Paracetamol and Topical anaesthetic drop with placebo in Retinopathy of Prematurity, sponsored by Dr. Sami Ulus Children's Hospital. Status unknown at 1 site in Turkey. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2013-06-07.

Sponsored by Dr. Sami Ulus Children's Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
Up to 3 Months
Sex
All
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Study summary

Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.

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Conditions studied

  • Retinopathy of Prematurity
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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Dr. Sami Ulus Children's Hospital is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 3 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • gestational age below 32 weeks or birth weight below 1500 grams

Exclusion criteria

Exclusion Criteria:

  • congenital anomalies, necrotising enterocolitis, surgical problems
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    local anasthetic drops

    topical anaesthetic drop with placebo

    Drug: Topical anaesthetic drop with placebo

  • Active comparator
    Paracetamol

    Topical anaesthetic drop with Paracetamol

    Drug: Paracetamol

Interventions

  • DrugParacetamol

    paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops

  • DrugTopical anaesthetic drop with placebo
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What researchers measure

Primary outcomes

  1. Reducing pain assessment score

    Time frame: 2 weeks

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Study locations

1 of 1 sites recruiting
  • Dr. Sami Ulus Childrens Hospital
    Ankara, 06080, Turkey
    • Serdar Beken, M.D · Contact · serbeken@gmail.com · 00903123056449
    • Serdar Beken, M.D · Principal investigator
    Recruiting
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References and documents

Publications

  • Allegaert K, Tibboel D, Naulaers G, Tison D, De Jonge A, Van Dijk M, Vanhole C, Devlieger H. Systematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed. Eur J Clin Pharmacol. 2003 Jun;59(2):87-90. doi: 10.1007/s00228-003-0585-3. Epub 2003 Apr 4. PubMed 12682806 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01872871
Lead sponsor
Dr. Sami Ulus Children's Hospital
Responsible party
Serdar Beken (M.D., Dr. Sami Ulus Children's Hospital) — Principal investigator
First posted
Jun 7, 2013
Start date
Jan 2013
Primary completion
Aug 2013 (estimated)
Completion
Jan 2014 (estimated)
Last update
Jun 7, 2013

Study contacts

Serdar Beken
Contact

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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