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Preemptive Analgesia Using Intravenous Paracetamol

Preemptive Analgesia Using Intravenous Paracetamol in Dental Sitting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02884921
Enrollment
87
Registered
2016-08-31
Start date
2015-04-30
Completion date
2016-08-31
Last updated
2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Anesthesia Outcome

Keywords

Postoperative pain, Dental treatment, Paracetamol

Brief summary

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.

Detailed description

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.

Interventions

DRUGParacetamol

Paracetamol

DRUGPlacebo

Placebo

Sponsors

Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* All children who require a wide treatment of caries * Children of high score of anxious or who is stressfully

Exclusion criteria

* Contraindication for paracetamol * Renal or hepatic insufficiency * Patient have history of allergy for paracetamol * Anemia of Hgb less than 10 gr/DL

Design outcomes

Primary

MeasureTime frameDescription
Pain measure in numerical scale1-24 hoursPost operative Pain measure in numerical scale from 1 to 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026