NCT01872871

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

June 4, 2013

Last Update Submit

June 6, 2013

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

  • Reducing pain assessment score

    2 weeks

Study Arms (2)

local anasthetic drops

PLACEBO COMPARATOR

topical anaesthetic drop with placebo

Drug: Topical anaesthetic drop with placebo

Paracetamol

ACTIVE COMPARATOR

Topical anaesthetic drop with Paracetamol

Drug: Paracetamol

Interventions

ParacetamolDRUG

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

Paracetamol
Topical anaesthetic drop with placeboDRUG
local anasthetic drops

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • congenital anomalies, necrotising enterocolitis, surgical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sami Ulus Childrens Hospital

Ankara, 06080, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 12682806BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Serdar Beken

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 7, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

January 1, 2014

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations

TU(1)