Post Operative Pain, Symptomatic Irreversible Pulpitis
Conditions
Keywords
Tramadol, Naproxen Sodium, Placebo
Brief summary
The goal of this clinical trial is to compare in Tramadol, Naproxen sodium and Placebo in participants presenting with irreversible pulpitis in their mandibular molar teeth. The main question\[s\] it aims to answer are: * Local anesthetic efficacy and . * Postoperative pain. Participants will receive premedication treatments 60 minutes prior to the local anesthesia administration. Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on Inferior alveolar nerve block efficacy and Postoperative pain.
Detailed description
The adult participants who report in out-patient department (OPD) of Operative Dentistry at Dow International Dental College with the symptoms of irreversible pulpitis will be screened for the participation in the study. A detailed history will be taken which will be followed by clinical examination and complemented with sensibility testing with Endo Ice or electric pulp test. Radiographic analysis will also be done to confirm the diagnosis to assess for factors pertaining to exclusion and inclusion criteria. Verbal and written informed consent will be taken from all the participants. Randomization: The participants will be randomly divided into 3 groups using a computer-generated randomization sequence (Microsoft Excel, Redmond, WA). The sequence was generated employing block randomization with an equal allocation ratio (1:1:1). Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only. Blinding: operator, participant and outcome assessor will be blinded. A paramedical staff will be trained in giving medication to the participants. Pain scores will be recorded by asking the participant to rate their pain on a scale ranging from 0 to 10 before medication and then after 15 minutes, 30 minutes and 60 minutes of administering the premedication. Pain score will also be recorded after 10 minutes of the administration of Inferior alveolar nerve block (IANBs) and buccal nerve block & during deroofing process of chamber opening. This step will serve as our primary outcome measure as anasthesia success rate. Two cartridges of Lidocaine 1.8 ml having a concentration of 1:100,000 of Epinephrine will be used for administration of regional anesthesia. Access opening will be performed under rubber dam isolation with a round bur in a high-speed hand piece with copious water irrigation. Sodium hypochlorite (5.25%) will be used as a standard root canal irrigation solution.Pulpectomy will be performed with the Protaper universal file system until the working lengths of the teeth under study. To assess the post-operative pain, a proforma and pain intensity scale will be provided to the participants for self recording at 6, 24, 48 and 72 hours after the procedure. The participants will return the proforma to an intern on 4th day to be assessed by an intern supervised by the principal investigator and assesed as secondary outcome of our study. (For this research, "The investigators will be offering As per need analgesic for breakthrough pain. Participants will be offered brufen 400mg as needed. The participants will be advised to mark breakthrough pain on VAS at the time of taking medicine). The participants will also be monitored for the adverse effects of these medications (nausea, vomiting, dizziness, drowsiness).
Interventions
DRUGTramadol
Tramadol 100mg will be given 60 minutes before start of procedure.
DRUGNaproxen Sodium
Naproxen sodium 550mg will be given 60 minutes before start of procedure.
DRUGPlacebo
Placebo will be given 60 minutes before start of procedure.
Sponsors
Dow University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Clinician and participants both will be blind to the medicine given to the participants. Participants will be given identical capsules by paramedical staff will be trained in giving medication to the participants. Outcome Assessor will be an intern who is not on research.
Intervention model description
The participants will be randomly divided into 3 groups. Computer software (Microsoft Excel, Redmond, WA) will be used to generate a random patient allocation sequence. Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen sodium 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA I and ASA II individuals who are between the ages of 18 and 60 years. * Patients who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis). * Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS= 1-10). * Mandibular permanent molars.
Exclusion criteria
* Patients who had taken painkillers or narcotics in the previous 12 hours * Patients suffering from severe pain because of traumatic occlusion. * Teeth with extensive damage, calcified canals, root resorption, and an open apex. * Previously root canal treated teeth. * Medically compromised patients (ASA-III and above) * Those with special communication needs or who do not understand Urdu or English language. * Pregnant and lactating women * Individual patients who will be driving back alone * Patients who are allergic to the prescribed medicines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Local Anesthesia Efficacy | During access cavity preparation (deroofing) | Local anesthesia efficacy was defined as absence of pain (VAS score ≤ 3) during access cavity preparation (deroofing) after inferior alveolar nerve block. Pain was assessed using a 10-point Visual Analog Scale (0 = no pain, 10 = worst pain). Participants were categorized as having successful anesthesia if VAS ≤ 3 and failure if VAS \> 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 6,24,48,72 hours post operatively | Postoperative pain was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain intensity. Pain scores were recorded at 6, 24, 48, and 72 hours postoperatively. Results are presented as median pain scores at each time point. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORTayyaba Tahira, BDS FCPS
Dow International Dental College, Dow University of Health Sciences
STUDY_DIRECTORFarah Naz, BDS FCPS
Dow International Dental College, Dow University of Health Sciences
Participant flow
Pre-assignment details
Of 145 eligible patients, 139 consented to participate in the study and to undergo the anesthetic and endodontic procedures. However, only 120 patients were evaluated for anesthetic efficacy and postoperative pain. This was due to 12 patients not recording VAS readings, 2 being excluded after access cavity preparation because of a lack of bleeding to confirm pulp vitality, and 5 requiring rescue medication after root canal treatment. Consequently, data from 120 patients were analyzed (Figure 1).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 31.25 Years |
| Preoperative pain scores on VAS | 8 score on scale |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 8 / 40 | 1 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
None listed