Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Pain

Treatments: Drug: Oral Analgesics; Drug: oral placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01971853

13-1753

Details and patient eligibility

About

All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.

Full description

To increase outcomes for patients receiving dental sedation by providing significant evidence that the new regimen improves the quality of sedation and results in an improved post sedation ability to eat, drink, resume normal activities and require less additional pain medications.

Enrollment: 88 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study.

Exclusion criteria

• Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

oral placebo

Placebo Comparator group

Description:

an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen

Treatment:

Drug: oral placebo

Oral Analgesics

Active Comparator group

Description:

5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen

Treatment:

Drug: Oral Analgesics