Effect of Oral Analgesics on Post-op Pain

NCT07204379 | Completed Early Phase 1 DMC

• 1 other identifier: AFID Safeena
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours - 72 hours

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

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

Other: No intervention?placebo

Novafen group

ACTIVE COMPARATOR

this group to be administered Novafen medication

Drug: Novafen

Tramadol group

ACTIVE COMPARATOR

this group to be administered Tramadol Medication

Drug: Tramadol

Naproxen group

ACTIVE COMPARATOR

this group to be administered Naproxen medication

Drug: Naproxen

Interventions

Novafen DRUG

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

Novafen group

Tramadol DRUG

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

Tramadol group

Naproxen DRUG

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

Naproxen group

No intervention?placebo OTHER

multivitamins to be administered in this group

Placebo group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Systemic disease
• Pregnant womens
• History of taking analgesics in previous 12 hrs or other drugs prior to presenting for treatment.

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

AFID

Rawalpindi, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

L 5409709; Tramadol; Naproxen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: patients to be divided into 4 equal groups and different drugs to be administered amongst each group and efficacy evaluated afterwards.

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 2, 2025
• Study Start: January 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 31, 2023
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)