Clinical trial
Valacyclovir Monotherapy in Pain Management of Acute Apical Abscesses After Performing Emergency Chamber Opening; A Randomized Clinical Trial
Name
2517
Description
This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess .
There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days
Trial arms
Trial start
2024-03-27
Estimated PCD
2024-04-01
Trial end
2024-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Valacyclovir 500 mg
Valtrex 2g immediate dose followed by 500mg 2 times daily for 3 days along with the analgesic (SOS, if needed) for 6 days
Arms:
Valacyclovir Group
Other names:
Valtrex 500mg, Naproxen Sodium 550mg (SOS)
Naproxen Sodium 550mg
550mg (as needed, SOS) for 6 days
Arms:
Control Group
Other names:
Synflex 550mg
Size
82
Primary endpoint
Changes in pain score using Numeric Rating Scale (NRS)
6 days
Eligibility criteria
Inclusion Criteria:
* Patient Age ≥18 years old
* Healthy patient American Society of Anesthesiologists (ASA) class l and ll.
* Patients having clinical evidence of pulp necrosis and acute apical abscess with radiographic signs of periapical disease.
* Main inclusion criteria is that patient should have moderate to severe pain, it can be calculated as:
1 to 3 as Mild pain. 4 to 6 as moderate pain. 7 to 10 as severe pain.
Exclusion Criteria:
* Patient currently on antibiotics or antivirals
* Smokers
* Unusual tooth anatomy or inaccurate diagnosis
* Pregnant or nursing mothers
* Patients allergic to valacyclovir
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 82, 'type': 'ESTIMATED'}}
Updated at
2024-04-10
1 organization
2 products
1 indication
Organization
Dow University of Health SciencesProduct
ValacyclovirIndication
Acute Apical AbscessProduct
Naproxen Sodium