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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03852602
Other study ID # 2019-18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 28, 2019
Est. completion date March 30, 2020

Study information

Verified date June 2021
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 30, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers
Gender All
Age group 3 Years to 7 Years
Eligibility 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: - Patients with mental or physical disabilities of any disease - Patients who have not undergone painful dental intervention under general anesthesia

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Preemptive Analgesics
Analgesic application15 minutes before the treatment
Control
Analgesic application15 minutes before the end of the treatment

Locations

Country Name City State
Turkey Sultan KELES Aydin

Sponsors (2)

Lead Sponsor Collaborator
Aydin Adnan Menderes University Inonu University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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