Post Operative PainEarly Phase 1NCT07204379
Effect of Oral Analgesics on Post-op Pain
A Early Phase 1 study testing Novafen, Tramadol and Naproxen in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
after 2 visit endodontics treatment, the analgesic efficacy of three different medications will be evaluated. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Novafen, Tramadol and Naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 31 Jul 2023
- Phase
- Early Phase 1
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1- Patients were aged between 20 and 60 years 2. Patients with moderate to severe spontaneous pain associated with irreversible pulpitis in single-rooted 3- premolars or anterior teeth with no clinical or radiographic signs or symptoms of acute or chronic apical periodontitis
Who cannot join
- Systemic disease
- Pregnant womens
- History of taking analgesics in previous 12 hrs or other drugs prior to presenting for treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Three Oral Analgesics on Postoperative Pain Following Root Canal Preparation: a Controlled Clinical Trial
after 2 visit endodontics treatment, the analgesic efficacy of three different medications will be evaluated.
Read the detailed description
Patients will be divided randomly into four groups of 25 patients each a control group receiving a single dose of a placebo (multivitamines) and three experimental groups receiving either a single dose of a Tramadol tablet (100 mg of Tramadol hydrochloride) Novafen capsules [325 mg of paracetamol (acetaminophen)], 200 mg of ibuprofen and 40 mg of caffeine anhydrous) or Naproxen tablets (500 mg of naproxen) immediately on completion of the first appointment. Balanced block random allocation will be made (12 blocks contained eight patients and one block contained four patients) by generating random digits via Microsoft Excel 2007. An Assistant who will be blinded to the aim and the protocol of the study generated the numbers. After explanation of the treatment procedures, treatment will be performed under rubber dam isolation by the dentist. The tooth will be anaesthetized using one cartridge of Ligocaine HCL 2%with Adenaline 0.001% injection 1.8ml (Septodont) local anaesthetic solution. If pain still remained during access cavity preparation, intrapulpal anaesthesia will be used as supplementary anaesthesia. The investigator who performed the root canal treatment will be blinded to the assignment. An access cavity will be prepared, and the working length will be determined electronically using an apex locator (Dentaport ZX; J. Morita, MFG,CORP) 1 mm short of the apex with a size 15 or 20 K-file and confirmed by periapical radiographs. The apical part of each root canal will be prepared to a size 25 K-file with the step- back technique in a circumferential manner. Normal saline (sodium chloride B.P0.9%W/V IV Infusion (sterifluid NS))will be used as the irrigant solution between each instrument. Canals will then be dried with paper points, and the access cavities will be restored temporarily with Cavit (3M ESPE, St Paul, MN, USA). Each patient's tablet/ capsule will be inserted into a sealed coded packet by a trained person who will be blinded to the drugs, and the packet remained sealed until it will be given to the patient. The patients will be supervised by one of the investigators when taking the oral medications. The intensity of the preoperative pain will then be measured by instructing the patient to complete a Visual Analogue Scale (VAS) before treatment and after 6, 12 and 24 h. At the second appointment, 24 h later the root canal treatment will be completed. The markings on the VAS will be measured, and the degree of pain will be categorized as mild (scores 1-3), moderate (scores 4-6) or severe (scores 7-10).
- Conditions
- Post Operative Pain
- Being tested
- Novafen, Tramadol, Naproxen, No intervention?placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovafenDrug
Novafen analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy
TramadolDrug
Tramadol analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy
NaproxenDrug
naproxen analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy
No intervention?placeboOther
multivitamins to be administered in this group
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | this group to be administered placebo medication (multi-vitamins) Receives: Other: No intervention?placebo |
| Novafen group | Active comparator | this group to be administered Novafen medication Receives: Drug: Novafen |
| Tramadol group | Active comparator | this group to be administered Tramadol Medication Receives: Drug: Tramadol |
| Naproxen group | Active comparator | this group to be administered Naproxen medication Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Post operative pain to be measured/evaluated in patients undergoing root canal therapy using visual analog scale (VAS). This is a numeric scale with readings 0-10. with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.
Measured: 6 hours - 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jan 2023
- Primary completion15 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients to be divided into 4 equal groups and different drugs to be administered amongst each group and efficacy evaluated afterwards.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safina Habib, Armed Forces Institute of Dentistry, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204379
- Sponsor's protocol ID
- AFID Safeena
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Oral Analgesics on Postoperative Pain Following Root Canal Preparation: a Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07204379
- Acronym / sponsor ID
- AFID Safeena
- Conditions
- Post Operative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 2 Oct 2025 (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.
after 2 visit endodontics treatment, the analgesic efficacy of three different medications will be evaluated.
Detailed description
Patients will be divided randomly into four groups of 25 patients each a control group receiving a single dose of a placebo (multivitamines) and three experimental groups receiving either a single dose of a Tramadol tablet (100 mg of Tramadol hydrochloride) Novafen capsules [325 mg of paracetamol (acetaminophen)], 200 mg of ibuprofen and 40 mg of caffeine anhydrous) or Naproxen tablets (500 mg of naproxen) immediately on completion of the first appointment. Balanced block random allocation will be made (12 blocks contained eight patients and one block contained four patients) by generating random digits via Microsoft Excel 2007. An Assistant who will be blinded to the aim and the protocol of the study generated the numbers. After explanation of the treatment procedures, treatment will be performed under rubber dam isolation by the dentist. The tooth will be anaesthetized using one cartridge of Ligocaine HCL 2%with Adenaline 0.001% injection 1.8ml (Septodont) local anaesthetic solution. If pain still remained during access cavity preparation, intrapulpal anaesthesia will be used as supplementary anaesthesia. The investigator who performed the root canal treatment will be blinded to the assignment. An access cavity will be prepared, and the working length will be determined electronically using an apex locator (Dentaport ZX; J. Morita, MFG,CORP) 1 mm short of the apex with a size 15 or 20 K-file and confirmed by periapical radiographs. The apical part of each root canal will be prepared to a size 25 K-file with the step- back technique in a circumferential manner. Normal saline (sodium chloride B.P0.9%W/V IV Infusion (sterifluid NS))will be used as the irrigant solution between each instrument. Canals will then be dried with paper points, and the access cavities will be restored temporarily with Cavit (3M ESPE, St Paul, MN, USA). Each patient's tablet/ capsule will be inserted into a sealed coded packet by a trained person who will be blinded to the drugs, and the packet remained sealed until it will be given to the patient. The patients will be supervised by one of the investigators when taking the oral medications. The intensity of the preoperative pain will then be measured by instructing the patient to complete a Visual Analogue Scale (VAS) before treatment and after 6, 12 and 24 h. At the second appointment, 24 h later the root canal treatment will be completed. The markings on the VAS will be measured, and the degree of pain will be categorized as mild (scores 1-3), moderate (scores 4-6) or severe (scores 7-10).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- patients to be divided into 4 equal groups and different drugs to be administered amongst each group and efficacy evaluated afterwards.
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: No intervention?placebothis group to be administered placebo medication (multi-vitamins) |
| Novafen group | Active comparator | Drug: Novafenthis group to be administered Novafen medication |
| Tramadol group | Active comparator | Drug: Tramadolthis group to be administered Tramadol Medication |
| Naproxen group | Active comparator | Drug: Naproxenthis group to be administered Naproxen medication |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1- Patients were aged between 20 and 60 years 2. Patients with moderate to severe spontaneous pain associated with irreversible pulpitis in single-rooted 3- premolars or anterior teeth with no clinical or radiographic signs or symptoms of acute or chronic apical periodontitis
Key exclusion criteria (3 listed)
- Systemic disease
- Pregnant womens
- History of taking analgesics in previous 12 hrs or other drugs prior to presenting for treatment.
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 |
|---|---|---|
| NovafenNovafen analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy | Drug | Novafen group |
| TramadolTramadol analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy | Drug | Tramadol group |
| Naproxennaproxen analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy | Drug | Naproxen group |
| No intervention?placebomultivitamins to be administered in this group | Other | Placebo group |
Primary outcome
Post operative pain
Time frame: 6 hours - 72 hours
Post operative pain to be measured/evaluated in patients undergoing root canal therapy using visual analog scale (VAS). This is a numeric scale with readings 0-10. with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.
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 2 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
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.
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 Early Phase 1 study testing Novafen, Tramadol and Naproxen in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
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 1 inclusion and 3 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 2 Oct 2025. 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 Pakistan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post operative pain (time frame: 6 hours - 72 hours). 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 2 Oct 2025.