PainNCT06574516
Pain Management Following Dental Treatment Under General Anesthesia
A study testing Ibuprofen 200 mg and paracetamol in people with Pain, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The main goal of this study is to test the efficacy of postoperative pain management for cases undergoing extractions of primary teeth under GA using a validated measure. Children undergoing extraction of at least one primary molar under general anesthesia GA at King Abdullah University Hospital (KAUH) were randomly… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Ibuprofen 200 mg and paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteJordan
- Study dates
- 4 Nov 2021to 9 Apr 2023
- Phase
- Interventional
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Fit and healthy patients, ASA I without cognitive or mental disabilities.
- Aged between 4-8 years.
- No preoperative moderate to severe pain.
- Not receiving pain medication prior to GA.
- Not allergic to any of the prescribed medications.
- Undergoing at least one posterior tooth extraction.
- Parent signed the consent form.
Who cannot join
- Children requiring extraction of permanent molars to ensure standardization.
- Patients who had no extractions at all.
- Cases of difficult intubation as pain of difficult intubation could be confused with dental pain
- Cases where it was necessary to repeat intra-operative analgesic medication (Fentanyl).
- Diclofenac sodium suppository was not given at the end of the procedure.
- Anesthetist did not follow the standardized anesthesia protocol existing in KAUH like cases where a sedative medication like Ketamine was given preoperatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence Of Effective Post-Operative Pain Management Following Dental Treatment Under General Anesthesia On Parental Satisfaction And Patient Outcomes
The main goal of this study is to test the efficacy of postoperative pain management for cases undergoing extractions of primary teeth under GA using a validated measure.
Children undergoing extraction of at least one primary molar under general anesthesia GA at King Abdullah University Hospital (KAUH) were randomly assigned into three groups: study group (1) were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, study group (2) were given Ibuprofen three times daily for 3 days, study group (3) were given Paracetamol prn for 3 days.
pain was assessed using parent's postoperative pain measure (PPPM) on the first, second and third days.
Read the detailed description
After ensuring the fulfillment of inclusion criteria, data were collected on three phases as follows:
Pre-Operative By interviewing the parents preoperatively during the waiting time, consent was obtained via a consent form , sociodemographic data (name, age, and date of the operation) were also collected using parental questionnaire .
Preoperative pain was measured using WBFPRS. Pre- and postoperative pain scales were explained to parents by the research assistant.
Intra-Operative Data were collected on anesthesia protocol , and dental treatment performed.
Anesthesia Protocol Data about anesthesia protocol were collected to ensure fulfilment of inclusion criteria, this includes mode of induction (IV or inhalational), tube type (nasal or oral), tube size, intra-operative medications (Dexamethasone and analgesia) doses and repetition , cases which did not fulfil the anesthesia protocol were excluded.
Dental Treatment Performed Data on dental procedures were collected including number of extracted teeth, location of extracted teeth (anterior, posterior), and length of dental procedure (in minutes)
Post-Operative Parents were interviewed in the hospital prior to discharge to assess pain 2 hours post operatively using parent's postoperative pain measure (PPPM).
Phone interviews were done to assess postoperative pain using PPPM at home by the same parent at the following intervals: on the night of the procedure, the next day before bed and on the third day before bed. Adherence of parents to pain control prescription was also reported.
- Conditions
- Pain
- Being tested
- Ibuprofen 200 mg, paracetamol
- Keywords
- post operative pain, extraction, general anesthesia
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 200 mgDrug
Also called Brufen
Ibuprofen every 8 hours for three days post operatively
paracetamolDrug
Also called Panadol
Paracetamol PRN for three days
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 (bimodal) | Experimental | participants were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, Receives: Drug: Ibuprofen 200 mg; Drug: paracetamol |
| study group 2 | Experimental | Participants were given Ibuprofen three times daily for 3 days Receives: Drug: Ibuprofen 200 mg |
| Control group | Active comparator | Paracetamol PRN based on parental assessment of pain Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of pain control using different medications
Reduction in pain scores using the parental post operative pain measure, by comparing scores immediately post operative with scores on subsequent days. higher scores indicate worse pain
Measured: 3 days post operative
Secondary outcomes (1)
Quality of life of treated children
Using Childhood Oral Health Impact Scale (ECOHIS), by comparing pre and postoperative scores, lower scores mean better quality of life
Measured: 2 weeks post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start4 Nov 2021
- Primary completion25 Aug 2022
- Study completion9 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574516
- Sponsor's protocol ID
- 448-2021
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence Of Effective Post-Operative Pain Management Following Dental Treatment Under General Anesthesia On Parental Satisfaction And Patient Outcomes
- ClinicalTrials.gov ID
- NCT06574516
- Acronym / sponsor ID
- 448-2021
- Conditions
- Pain
- Keywords
- post operative pain, extraction, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 9 Apr 2023 (actual)
- First posted
- 28 Aug 2024 (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 main goal of this study is to test the efficacy of postoperative pain management for cases undergoing extractions of primary teeth under GA using a validated measure.
Children undergoing extraction of at least one primary molar under general anesthesia GA at King Abdullah University Hospital (KAUH) were randomly assigned into three groups: study group (1) were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, study group (2) were given Ibuprofen three times daily for 3 days, study group (3) were given Paracetamol prn for 3 days.
pain was assessed using parent's postoperative pain measure (PPPM) on the first, second and third days.
Detailed description
After ensuring the fulfillment of inclusion criteria, data were collected on three phases as follows:
Pre-Operative By interviewing the parents preoperatively during the waiting time, consent was obtained via a consent form , sociodemographic data (name, age, and date of the operation) were also collected using parental questionnaire .
Preoperative pain was measured using WBFPRS. Pre- and postoperative pain scales were explained to parents by the research assistant.
Intra-Operative Data were collected on anesthesia protocol , and dental treatment performed.
Anesthesia Protocol Data about anesthesia protocol were collected to ensure fulfilment of inclusion criteria, this includes mode of induction (IV or inhalational), tube type (nasal or oral), tube size, intra-operative medications (Dexamethasone and analgesia) doses and repetition , cases which did not fulfil the anesthesia protocol were excluded.
Dental Treatment Performed Data on dental procedures were collected including number of extracted teeth, location of extracted teeth (anterior, posterior), and length of dental procedure (in minutes)
Post-Operative Parents were interviewed in the hospital prior to discharge to assess pain 2 hours post operatively using parent's postoperative pain measure (PPPM).
Phone interviews were done to assess postoperative pain using PPPM at home by the same parent at the following intervals: on the night of the procedure, the next day before bed and on the third day before bed. Adherence of parents to pain control prescription was also reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group 1 (bimodal) | Experimental | Drug: Ibuprofen 200 mg, Drug: paracetamolparticipants were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, |
| study group 2 | Experimental | Drug: Ibuprofen 200 mgParticipants were given Ibuprofen three times daily for 3 days |
| Control group | Active comparator | Drug: paracetamolParacetamol PRN based on parental assessment of pain |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Fit and healthy patients, ASA I without cognitive or mental disabilities.
- Aged between 4-8 years.
- No preoperative moderate to severe pain.
- Not receiving pain medication prior to GA.
- Not allergic to any of the prescribed medications.
Key exclusion criteria (6 listed)
- Children requiring extraction of permanent molars to ensure standardization.
- Patients who had no extractions at all.
- Cases of difficult intubation as pain of difficult intubation could be confused with dental pain
- Cases where it was necessary to repeat intra-operative analgesic medication (Fentanyl).
- Diclofenac sodium suppository was not given at the end of the procedure.
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 |
|---|---|---|
| Ibuprofen 200 mgAlso: BrufenIbuprofen every 8 hours for three days post operatively | Drug | Study group 1 (bimodal), study group 2 |
| paracetamolAlso: PanadolParacetamol PRN for three days | Drug | Control group, Study group 1 (bimodal) |
Primary outcome
Efficacy of pain control using different medications
Time frame: 3 days post operative
Reduction in pain scores using the parental post operative pain measure, by comparing scores immediately post operative with scores on subsequent days. higher scores indicate worse pain
1 secondary outcome
Quality of life of treated children
Time frame: 2 weeks post operative
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 4 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen 200 mg and paracetamol in people with Pain, run by King Abdullah University Hospital at 1 site in Jordan.
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 7 inclusion and 6 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 4 Sep 2024. 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 Jordan. 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?
Efficacy of pain control using different medications (time frame: 3 days post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2024.