Postoperative Pain
Conditions
Keywords
postoperative pain, root canal treatment
Brief summary
The purpose of this study is to evaluate patients with emergency pain and a sore (infected) tooth to determine if immediate root canal therapy is better at reducing pain, when compared to initial treatment with antibiotic and pain medication followed by root canal therapy. Each participant will be randomly assigned a number, which will determine if they will receive initial endodontic treatment that day or at a later date. Each participant will receive an anesthetic injection, pain medication and a prescription for an antibiotic. They will be asked to keep a diary to record their pain level after the injection and their pain levels and the amount and type of pain medication taken each day for the next 5 days. Participants who did not receive root canal therapy at the initial appointment will receive it after the 5 day postoperative period. The pain levels and medication use will be compared between the treatment and nontreatment groups.
Interventions
PROCEDUREroot canal treatment, anesthesia, pain medications, and antibiotic
Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.
PROCEDUREno root canal treatment, anesthesia, pain medications, and antibiotic
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * in good health (ASA classification I or II) * able to give informed consent * infected tooth with toothache (symptomatic tooth with pulpal necrosis)
Exclusion criteria
* allergy to ibuprofen, acetaminophen or codeine * history of significant medical problems (ASA classification III or greater) * angioedema or bronchospastic reactivity to aspirin or other NSAIDs * pregnant or lactating * inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use | each day for 5 days | pain measurement as assessed on a visual analog scale and pain medication usage definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Root Canal Treatment root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)
root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device. | 46 |
| no Root Canal Treatment no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)
no root canal treatment | 49 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 3 |
Baseline characteristics
| Characteristic | Root Canal Treatment | no Root Canal Treatment | Total |
|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 12.1 | 39.1 years STANDARD_DEVIATION 16.1 | 37.7 years STANDARD_DEVIATION 14.1 |
| Region of Enrollment United States | 46 participants | 49 participants | 95 participants |
| Sex: Female, Male Female | 20 Participants | 25 Participants | 45 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 56 | 0 / 52 |
| serious Total, serious adverse events | 0 / 56 | 0 / 52 |
Outcome results
Primary
Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use
pain measurement as assessed on a visual analog scale and pain medication usage definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success.
Time frame: each day for 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Root Canal Treatment | Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use | 52 percentage of participants |
| no Root Canal Treatment | Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use | 43 percentage of participants |