Preemptive Analgesia Using Intravenous Paracetamol
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|ClinicalTrials.gov Identifier: NCT02884921|
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Dental treatment for children should be done in a calm atmosphere and without pain. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models.
There are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.
The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention of postoperative pain in children undergoing dental treatment.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Anesthesia Outcome||Drug: Paracetamol Drug: Placebo||Not Applicable|
Dental treatment for children should be done in a calm atmosphere and without pain in purpose to achieve a positive feelings and response towards dental treatment.Postoperative pain is the main issue which may cause a negative attitude of the child to dental treatment in future appointment. One of the affective options to deal with this pain is to give analgesic drug before the initiative of treatment which should continue its effect during and may also after treatment which is known as "preemptive analgesia. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models. In double blind clinical trials single or multiple dose of intravenous paracetamol, generally provided significantly better analgesic effect than placebo treatment in adults' patients who had undergone dental, orthopedic or gynecological surgery. There is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of prostaglandin synthesis by its selective inhibition of Cox-2 isoenzyme.
At the best of the investigators knowledge, there are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.
The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention or modification of postoperative pain in children undergoing dental treatment.
The primary outcome of this study is to investigate the post dental treatment analgesic effect of intravenous paracetamol in children when administered before compared to after dental treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Preemptive Analgesia Using Intravenous Paracetamol in Dental Sitting|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||August 2016|
Active Comparator: Preemptive Paracetamol
Active Comparator: Post surgery Paracetamol
Post surgery Paracetamol
Placebo Comparator: Placebo
- Pain measure in numerical scale [ Time Frame: 1-24 hours ]Post operative Pain measure in numerical scale from 1 to 10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884921
|Study Chair:||mira koch||Ethicla Committee Bnai Zion Medical Center|