Preemptive Analgesia Using Intravenous Paracetamol

Adverse Anesthesia Outcome Clinical Trial

Official title:

Preemptive Analgesia Using Intravenous Paracetamol in Dental Sitting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884921
• Other study ID #: BnaiZionMC-16-LG-008
• Status: Completed
• Phase: N/A
• First received: August 21, 2016
• Last updated: August 30, 2016
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

Drug:
• Paracetamol
Paracetamol
• Paracetamol
Paracetamol
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measure in numerical scale	Post operative Pain measure in numerical scale from 1 to 10	1-24 hours	Yes