Effect of Oral Analgesics on Post-op Pain

Armed Forces Institute of Dentistry, Pakistan

Status and phase: Completed; Early Phase 1

Conditions: Post Operative Pain

Treatments: Other: No intervention?placebo; Drug: Tramadol; Drug: Naproxen; Drug: Novafen

Study type: Interventional

Funder types: Other

Identifiers

NCT07204379

AFID Safeena

Details and patient eligibility

About

after 2 visit endodontics treatment, the analgesic efficacy of three different medications will be evaluated.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 4 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: No intervention?placebo

Novafen group

Active Comparator group

Description:

this group to be administered Novafen medication

Treatment:

Drug: Novafen

Tramadol group

Active Comparator group

Description:

this group to be administered Tramadol Medication

Treatment:

Drug: Tramadol

Naproxen group

Active Comparator group

Description:

this group to be administered Naproxen medication

Treatment:

Drug: Naproxen