Health Condition 1: null- Indication for forceps extraction of one or more teeth and expected to experience pain.
Conditions
Interventions
Intervention1: Imipramine with ibuprofen: imipramine (25 mg p.o.) will be given 30 minutes before extraction procedure follwed by 400 mg of ibuprofen
Control Intervention1: Matching Placebo and ibupro
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Age between 18 to 30 years. Either sex. Indication for forceps extraction of one or more teeth and expected to experience pain. Willing to give informed consent
Exclusion criteria
Exclusion criteria: Grade 3 mobile tooth. Any local or systemic conditions contraindicating tooth extraction Pregnancy or breast-feeding Alcohol or substance abuse Any serious medical or psychiatric disorder History of stomach ulcers, stomach bleed, or other bleeding disorders Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other NSAID; paracetamol; or codeine or any other opioid is contraindicated (including: antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol]) Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPRID 0-6 (sum of pain intensity difference scores and pain relief scores from 0 to 6 hours after dosing)Timepoint: SPRID 0-6 (sum of pain intensity difference scores and pain relief scores from 0 to 6 hours after dosing) | — |
Secondary
| Measure | Time frame |
|---|---|
| SPRID2, and SPRID3 post-dosing, TOTPAR2, TOTPAR3, and TOTPAR6.Timepoint: 0, 2 and 6 hour;The cumulative proportion of subjects achieving "meaningful" and "first perceptible" relief (confirmed by "meaningful" relief) by each post-dosing time-point.Timepoint: 0, 2 and 6 hour | — |
Countries
India
Contacts
Public ContactDr Debasish Hota
Outcome results
None listed