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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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oral placebo

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

Group Type PLACEBO_COMPARATOR

oral placebo

Intervention Type DRUG

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

Oral Analgesics

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

Group Type ACTIVE_COMPARATOR

Oral Analgesics

Intervention Type DRUG

Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen

Interventions

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oral placebo

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

Intervention Type DRUG

Oral Analgesics

Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen

Intervention Type DRUG

Other Intervention Names

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Flavored liquid

Eligibility Criteria

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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.