Effect of Oral Analgesics on Post-op Pain

NCT ID: NCT07204379

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-07-31

Brief Summary

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).

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo group

this group to be administered placebo medication (multi-vitamins)

Group Type: PLACEBO_COMPARATOR

No intervention?placebo

Intervention Type: OTHER

multivitamins to be administered in this group

Novafen group

this group to be administered Novafen medication

Group Type: ACTIVE_COMPARATOR

Novafen

Intervention Type: DRUG

Novafen analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy

Tramadol group

this group to be administered Tramadol Medication

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

Tramadol analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy

Naproxen group

this group to be administered Naproxen medication

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

naproxen analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy

Interventions

Novafen

Novafen analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy

Intervention Type: DRUG

Tramadol

Tramadol analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy

Intervention Type: DRUG

Naproxen

naproxen analgesic medication to be administered as pain painkiller in one group of patients undergoing root canal therapy

Intervention Type: DRUG

No intervention?placebo

multivitamins to be administered in this group

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. Systemic disease

2. Pregnant womens

3. History of taking analgesics in previous 12 hrs or other drugs prior to presenting for treatment.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Armed Forces Institute of Dentistry, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Safina Habib

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AFID

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

AFID Safeena

Identifier Type: -

Identifier Source: org_study_id