Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03852602
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
Inonu University
Information provided by (Responsible Party):
Sultan KELES, Aydin Adnan Menderes University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : February 28, 2019
Actual Primary Completion Date : February 15, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort 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 Name: 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Postoperative dental pain [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Children who will be treated under general anesthesia because of lack of chairside cooperation.
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852602


Locations
Layout table for location information
Turkey
Sultan KELES
Aydin, Turkey, 09100
Sponsors and Collaborators
Aydin Adnan Menderes University
Inonu University
Investigators
Layout table for investigator information
Study Chair: Sultan Keles, Dr. Aydin Adnan Menderes University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Sultan KELES, Assist. Prof.Dr., Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03852602    
Other Study ID Numbers: 2019-18
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study will be conducted and then will be published.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs