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

Sponsor

Aydin Adnan Menderes University (Other)

Overall Status

Completed

CT.gov ID

NCT03852602

Collaborator

Inonu University (Other)

Enrollment

Location

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Preemptive Analgesics Drug: Control

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.

Study Design

Study Type:

Observational

Actual Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 28, 2019

Actual Primary Completion Date :

Feb 15, 2020

Actual Study Completion Date :

Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group Control Analgesic application15 minutes before the end of the treatment will constitute the control group.	Drug: Control Analgesic application15 minutes before the end of the treatment Other Names: Preventive analgesic
Group preemptive Patients who underwent analgesic 15 minutes after the induction of general anesthesia .	Drug: Preemptive Analgesics Analgesic application15 minutes before the treatment

Arm

Intervention/Treatment

Group Control

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

Drug: Control

Analgesic application15 minutes before the end of the treatment

Other Names:

Preventive analgesic

Group preemptive

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

Drug: Preemptive Analgesics

Analgesic application15 minutes before the treatment

Outcome Measures

Primary Outcome Measures

Postoperative dental pain [An average of 24 hours postoperatively]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 7 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sultan KELES	Aydin		Turkey	09100

Sponsors and Collaborators

Aydin Adnan Menderes University
Inonu University

Investigators

Study Chair: Sultan Keles, Dr., Aydin Adnan Menderes University

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Sultan KELES, Assist. Prof.Dr., Aydin Adnan Menderes University

ClinicalTrials.gov Identifier:

NCT03852602

Other Study ID Numbers:

2019-18

First Posted:

Feb 25, 2019

Last Update Posted:

Jun 14, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Analgesics

Study Results

No Results Posted as of Jun 14, 2021