Preemptive Analgesia Using Intravenous Paracetamol

Bnai Zion Medical Center

Status: Completed

Conditions: Adverse Anesthesia Outcome

Treatments: Drug: Paracetamol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02884921

BnaiZionMC-16-LG-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

87 participants in 3 patient groups, including a placebo group

Preemptive Paracetamol

Active Comparator group

Description:

Preemptive Paracetamol

Treatment:

Drug: Paracetamol

Drug: Paracetamol

Post surgery Paracetamol

Active Comparator group

Description:

Post surgery Paracetamol

Treatment:

Drug: Paracetamol

Drug: Paracetamol

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo