Registration and Treatment of Pain During Eye Examination of Prematurity

NCT01552993 | Terminated

• 1 other identifier: HB2012-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.

Conditions

Infant, Premature; Retinopathy

Keywords

prematurity; retinopathy; pain; acetaminophen

Outcome Measures

Primary Outcomes (1)

• pain

  Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers

  5 minutes

Study Arms (2)

paracetamol

EXPERIMENTAL

Paracetamol mixture 20 mg/kg + pacifier and sucrose

Drug: paracetamol

placebo

PLACEBO COMPARATOR

pacifier and sucrose only

Drug: sucrose

Interventions

paracetamol DRUG

Paracetamol mixture 20 mg/kg + pacifier and glucose

paracetamol

sucrose DRUG

pacifier and sucrose

placebo

Eligibility Criteria

• Age: 31 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants \< 32 weeks of gestational age (\< 31+6 weeks)

You may not qualify if:

• Infants with ongoing analgesic treatment

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St.Olavs University Hospital

Trondheim, Trøndelag, 7006, Norway

Location

MeSH Terms

Conditions

Premature Birth; Retinal Diseases; Pain

Interventions

Acetaminophen; Sucrose

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eye Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Hakon Bergseng, PhD

  St. Olavs University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 13, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

NO (1)