NCT03852602

Brief Summary

The aim of this study was to compare the analgesic-treated children with analgesic prior to the treatment and to compare the postoperative analgesic needs of children undergoing dental treatment under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 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

First Submitted

Initial submission to the registry

February 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

February 18, 2019

Last Update Submit

June 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative dental pain

    Wong-Baker faces Scale is validated for children aged 3 to 7 years, includes six cartoon faces corresponding to scores 0-5 (0=no hurt, 1= hurts a little bit, 2= hurts a little more, 3=hurts even more, 4= hurts a whole lot, 5=hurts worst).

    An average of 24 hours postoperatively

Study Arms (2)

Group Control

Analgesic application15 minutes before the end of the treatment will constitute the control group.

Drug: Control

Group preemptive

Patients who underwent analgesic 15 minutes after the induction of general anesthesia .

Drug: Preemptive Analgesics

Interventions

Analgesic application15 minutes before the treatment

Group preemptive

Analgesic application15 minutes before the end of the treatment

Also known as: Preventive analgesic
Group Control

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children who will be treated under general anesthesia because of lack of chairside cooperation.

You may qualify if:

  • To be treated under general anesthesia
  • No systemic disease
  • To have at least one painful dental procedure in the upper and lower jaw (pulpectomy, pulpotomy

You may not qualify if:

  • Patients with mental or physical disabilities of any disease
  • Patients who have not undergone painful dental intervention under general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan KELES

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (1)

  • Kharouba J, Hawash N, Peretz B, Blumer S, Srour Y, Nassar M, Sabbah M, Safadi A, Khorev A, Somri M. Effect of intravenous paracetamol as pre-emptive compared to preventive analgesia in a pediatric dental setting: a prospective randomized study. Int J Paediatr Dent. 2018 Jan;28(1):83-91. doi: 10.1111/ipd.12311. Epub 2017 Jun 15.

    PMID: 28618198BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sultan Keles, Dr.

    Aydin Adnan Menderes University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.Dr.

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 25, 2019

Study Start

February 28, 2019

Primary Completion

February 15, 2020

Study Completion

March 30, 2020

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations