Randomized, trial evaluating efficacy of add-on imipramine in the control of Dental Pai
- Conditions
- Health Condition 1: null- Indication for forceps extraction of one or more teeth and expected to experience pain.
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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