NCT04608669

Brief Summary

Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

October 24, 2020

Last Update Submit

March 17, 2021

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

  • Temperature variation

    3 months

Study Arms (2)

Temperature comparison

OTHER
Drug: Paracetamol

No change

ACTIVE COMPARATOR
Drug: Paracetamol

Interventions

ParacetamolDRUG

Give paracetamol or placebo and compare temperature

No changeTemperature comparison

Eligibility Criteria

Age0 Days - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Georges hospital

Beirut, Lebanon

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 24, 2020

First Posted

October 29, 2020

Study Start

July 1, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2020

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

LE(1)