Pain, PostoperativeNCT03852602
Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia
An observational study of Pain, Postoperative, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Preemptive Analgesics
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2019to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Child
Study population: Children who will be treated under general anesthesia because of lack of chairside cooperation.
Who may be able to join
- 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
Who cannot join
- Patients with mental or physical disabilities of any disease
- Patients who have not undergone painful dental intervention under general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia in Children
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.
- Conditions
- Pain, Postoperative
- Being tested
- Preemptive Analgesics, Control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive AnalgesicsDrug
Analgesic application15 minutes before the treatment
ControlDrug
Also called Preventive analgesic
Analgesic application15 minutes before the end of the treatment
| Study group | Role | What they receive |
|---|---|---|
| Group Control | Analgesic application15 minutes before the end of the treatment will constitute the control group. Receives: Drug: Control | |
| Group preemptive | Patients who underwent analgesic 15 minutes after the induction of general anesthesia . Receives: Drug: Preemptive Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: An average of 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start28 Feb 2019
- Primary completion15 Feb 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Principal investigator, Sultan KELES, Aydin Adnan Menderes University
- Investigators
- Sultan Keles, Dr., Study chair, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852602
- Sponsor's protocol ID
- 2019-18
- Status last verified
- Jun 2021
- First submitted
- 18 Feb 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study will be conducted and then will be published.
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia in Children
- ClinicalTrials.gov ID
- NCT03852602
- Acronym / sponsor ID
- 2019-18
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control | – | Drug: ControlAnalgesic application15 minutes before the end of the treatment will constitute the control group. |
| Group preemptive | – | Drug: Preemptive AnalgesicsPatients who underwent analgesic 15 minutes after the induction of general anesthesia . |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Children who will be treated under general anesthesia because of lack of chairside cooperation.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with mental or physical disabilities of any disease
- Patients who have not undergone painful dental intervention under general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preemptive AnalgesicsAnalgesic application15 minutes before the treatment | Drug | Group preemptive |
| ControlAlso: Preventive analgesicAnalgesic application15 minutes before the end of the treatment | Drug | Group Control |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Background: PubMed 28618198Kharouba 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.
- Individual participant dataSharing planned: Undecided. Study will be conducted and then will be published.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sultan Keles, Dr. study chair
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative dental pain (time frame: An average of 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.