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

NCT ID: NCT01872871

Last Updated: 2013-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Retinopathy of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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local anasthetic drops

topical anaesthetic drop with placebo

Group Type PLACEBO_COMPARATOR

Topical anaesthetic drop with placebo

Intervention Type DRUG

Paracetamol

Topical anaesthetic drop with Paracetamol

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

Interventions

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Paracetamol

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

Intervention Type DRUG

Topical anaesthetic drop with placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* congenital anomalies, necrotising enterocolitis, surgical problems
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Sami Ulus Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Serdar Beken

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Sami Ulus Childrens Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Serdar Beken

Role: CONTACT

Facility Contacts

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Serdar Beken, M.D

Role: primary

00903123056449

References

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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.

Reference Type BACKGROUND
PMID: 12682806 (View on PubMed)

Other Identifiers

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B.10.4.İSM.4.06.68.49

Identifier Type: REGISTRY

Identifier Source: secondary_id

B.10.4.İSM.4.06.68.49/231

Identifier Type: -

Identifier Source: org_study_id

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