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CompletedNCT03852602Updated Jun 14, 2021

Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia

An observational study in Pain, Postoperative, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by Aydin Adnan Menderes University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
3 Years to 7 Years
Sex
All
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Study 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.

Read the detailed description

The investigator's study included patients who were admitted to Inonu University and Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry in 2019 and decided to perform dental treatment under general anesthesia. Patients 1 to 7 years of age with dental treatment between February 28 and June 1, 2019 will be included.

Patients who underwent analgesic 15 minutes after the induction of general anesthesia from the patients, and those who made painkillers 15 minutes before the end of the treatment will constitute the control group. Paracetamol 15 mg / kg IV will be given in 50 ml of saline.

The demographic data of the children to be included in the study such as age, gender, type of dental intervention, duration of operation, postoperative pain scores, recovery times will be recorded and compared.

02

Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's enrollment of 70 is below the median of 102 across 607 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugPreemptive Analgesics

    Analgesic application15 minutes before the treatment

  • DrugControl

    Analgesic application15 minutes before the end of the treatment

    Also known as: Preventive analgesic

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What researchers measure

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).

    Time frame: An average of 24 hours postoperatively

07

Study locations

1 site
  • Sultan KELES
    Aydin, 09100, Turkey
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References and documents

Publications

  • 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. PubMed 28618198 ↗

Individual participant data

Plan to share: Undecided — Study will be conducted and then will be published.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03852602
Lead sponsor
Aydin Adnan Menderes University
Collaborators
Inonu University
Responsible party
Sultan KELES (Assist. Prof.Dr., Aydin Adnan Menderes University) — Principal investigator
First posted
Feb 25, 2019
Start date
Feb 28, 2019
Primary completion
Feb 15, 2020
Completion
Mar 30, 2020
Last update
Jun 14, 2021

Study contacts

Sultan Keles, Dr.
study chair · Aydin Adnan Menderes University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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