Role of Alprazolam in Management of Post Endodontic Pain After Single Visit Root Canal Treatment. To Compare Mean Pain Score Between Two Group of Participants Undergoing Post Operative Pain Management After Single Visit Root Canal Treatment: NSAIDs Alone and a Combination of NSAIDs and Alprazolam.

NCT07275710 | Not Yet Recruiting

• 1 other identifier: OD2025-PAIN-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

To compare mean pain score between two group of participants undergoing post operative pain management after single visit root canal treatment: one group receiving NSAIDs alone and the other receiving a combination of NSAIDs and an anxiolytic medication i.e alprazolam.

Conditions

Pain

Keywords

post endodontic pain; root canal treatment; alprazolam

Outcome Measures

Primary Outcomes (1)

• pain levels

  patients will be randomly assigned to one of two groups: * Group 1: Ibuprofen 400 mg (Abbott Brufen) * Group 2: Ibuprofen 400 mg (Abbott Brufen) + Alprazolam 0.5 mg (Hilton Pharma Alp) Pain Assessment Participants will be provided with a pain diary containing a 10 cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). They will record their pain intensity at 6, 12, and 24 hours after treatment. Pain diaries will be collected during the one-week follow-up visit. Data will be used to compare mean VAS scores between groups to evaluate the efficacy of the two analgesic regimens.

  6 hours 12 hours 24 hours

Study Arms (2)

brufen

ACTIVE COMPARATOR

one group in the study will be prescribed 400mg ibuprofen tablet for management of post endodontic pain after root canal treatment and patient will be asked to score their pain level at 6, 12 and 24 hours on visual analogue scale.

Drug: Brufen

alprazolam

ACTIVE COMPARATOR

second group in the study will be prescribed 0.5mg alp tablet for management of post endodontic pain after root canal treatment and patient will be asked to score their pain level at 6, 12 and 24 hours on visual analogue scale.

Combination Product: Brufen and alprazolam

Interventions

Brufen and alprazolam COMBINATION_PRODUCT

second group in the study will be prescribed 400mg ibuprofen and 0.5mg alp tablet for management of post endodontic pain after root canal treatment

alprazolam

Brufen DRUG

one group in the study will be prescribed 400mg ibuprofen for management of post endodontic pain after root canal treatment

brufen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients aged between 18-60 years
• healthy patients with ASA classification I and II
• Teeth with symptomatic irreversible pulpitis

You may not qualify if:

• patient suffering from systemic disease that requires antibiotics
• pregnant or lactating mothers
• teeth with periapical radiolucency
• teeth with severe periodontitis
• patients who have taken analgesics 12 hours prior to procedure
• patients already taking benzodiadepines

Sponsors & Collaborators

• Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi: lead

Study Sites (1)

Armed Forces Post Graduate Medical Institute

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (1)

• Baradaran M, Hamidi MR, Moghimi Firoozabad MR, Kazemi S, Ashrafpour M, Moghadamnia AA. Alprazolam role in the analgesic effect of ibuprofen on postendodontic pain. Caspian J Intern Med. 2014 Fall;5(4):196-201.

  PMID: 25489429 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen; Alprazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

tahreem qureshi

CONTACT

0333-0209209; tahreemqureshi97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 10, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)