The effect of clonidine as an adjunct to lidocaine on postoperative pain control following root canal treatment

• Register: ISRCTN
• Last refreshed on: 30 January 2023
• Main ID: ISRCTN70419178
• Date of registration: 29/12/2016
• Prospective Registration: No
• Primary sponsor: Isfahan University of Medical Sciences
• Public title: The effect of clonidine as an adjunct to lidocaine on postoperative pain control following root canal treatment
• Scientific title: The effect of clonidine as an adjunct to lidocaine on postoperative pain control following root canal treatment: a prospective randomized double-blind study
• Date of first enrolment: 15/11/2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN70419178
• Study type: Interventional
• Study design: Randomized controlled double-blind clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Iran

Contacts

• Name: Elham Shadmehr

Key inclusion & exclusion criteria

Inclusion criteria:
1. Adult patients (18 years of age or older)
2. In good medical condition (American Society of Anesthesiologists classification 1)
3. Diagnosed with symptomatic irreversible pulpitis and normal/symptomatic apical periodontitis at the mandibular first or second molars

Exclusion criteria:
1. Patients with active signs of oral infections or inflammation
2. History of addiction or use of ß blockers
3. Patients taking any medications that could affect anesthetic assessment (analgesics or opioids at least one week before treatments)
4. Patients with allergies or contraindications to the use of clonidine, epinephrine or ibuprofen
5. Female patients who were pregnant or breastfeeding
6. Patients with no response to cold testing
7. Perirapical pathosis (other than a widened periodontal ligament)
8. No vital coronal pulp tissue upon access cavity preparation (partial necrosis)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative pain after root canal treatment
Oral Health

Intervention(s)

Patients are randomised to one of two groups.

Group 1: Patients receive 1.8 mL of 2% lidocaine with clonidine (15 µg/mL) using a conventional inferior alveolar nerve block (IANB).
Group 2: Patients receive 1.8 mL of 2% lidocaine with epinephrine (1:80,000) using a conventional inferior alveolar nerve block (IANB).

All treatments are completed in a single-visit appointment. Pain scores are recorded preoperatively and at 6, 12, 24, 36, 48, and 72 hours after endodontic treatment using a Heft-Parker visual analog scale (VAS). Also, the total number of tablets of analgesics consumed by the patient are also recorded and analyzed by chi-squared, paired t-test and repeated measure of ANOVA (p<0.05).

Primary Outcome(s)

1. Pain scores, recorded using a Heft-Parker visual analog scale (VAS) preoperatively and at 6, 12, 24, 36, 48, and 72 hours after endodontic treatment
2. Number of pain medications consumed are recorded continuously for 72 hours postoperatively

Secondary Outcome(s)

Duration of postoperative pain is assessed using a visual analog scale (VAS) preoperatively and at 6, 12, 24, 36, 48, and 72 hours

Secondary ID(s)

142287

Source(s) of Monetary Support

Isfahan University of Medical Sciences

Ethics review

Status:
Approval date:
Contact:

Isfahan University of Medical Sciences, 14/04/2014, ref: 142287

Results

• Results available: Yes
• Date Completed: 15/01/2016