Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia

Boston University

Status and phase

Enrolling

Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Ibuprofen

Drug: Acetominophen

Study type

Interventional

Funder types

Other

Identifiers

NCT06757075

H-001FC

Details and patient eligibility

About

The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures.

The analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.

Enrollment

75 estimated patients

Sex

All

Ages

4 to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

American Society of Anesthesiologists (ASA) I-II
Requiring Oral Rehabilitation under General Anesthesia
Possess legal guardians proficient in English
Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen

Exclusion criteria

ASA III or IV
Asthma diagnosis
Contraindication to acetaminophen or ibuprofen

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

Alternating analgesics

Experimental group

Description:

Participants randomized into this arm will be given alternating Ibuprofen and Acetaminophen every 6 hours, alternating the two medications every 3 hours: first dose ibuprofen, three hours later acetaminophen for 24 hours.

Treatment:

Drug: Acetominophen

Drug: Ibuprofen

Simultaneous post-operative analgesics

Experimental group

Description:

Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.

Treatment:

Drug: Acetominophen

Drug: Ibuprofen

Control Standard of Care

Active Comparator group