Acetaminophen's Efficacy For Post-operative Pain

NCT01721486 | Completed Phase 4 Results DMC

• 1 other identifier: 2012-162
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.

Conditions

Tonsillitis; Airway Obstruction; Difficulty Swallowing

Keywords

tonsillitis; recurrent tonsillitis; obstructed air passages; swallowing difficulties

Outcome Measures

Primary Outcomes (1)

• Total Pain Medication

  All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.

  From time of PACU admission until 24 hours post-operatively.

Secondary Outcomes (3)

• FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores

  At time of admission into PACU.

• Incidence of Post-operative Vomiting

  From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.

• Parental Satisfaction With Pain Control.

  24 hours post hospital discharge.

Study Arms (2)

Study Group

EXPERIMENTAL

IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.

Drug: IV acetaminophen

Control Group

ACTIVE COMPARATOR

PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.

Drug: PO acetaminophen

Interventions

IV acetaminophen DRUG

IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .

Also known as: Ofirmev

Study Group

PO acetaminophen DRUG

PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.

Also known as: Acetaminophen Elixir

Control Group

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 5-13 years of age
• Surgical procedure: tonsillectomy with or without adenoidectomy
• American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness or mild systemic disease that is well-controlled, e.g. mild asthma)

You may not qualify if:

• Known allergy to study medication(s)
• Known genetic abnormality
• Known hepatitis
• Children with other physical, mental or medical conditions which, in the opinion of the PI, make study participation inadvisable or impairs pain assessment
• Children who have taken any analgesic within 24 hours prior to surgery
• Enrollment in concurrent research study
• Pregnant patients\*
• Students/trainees/staff\*
• Mentally disabled/cognitively impaired\*

Sponsors & Collaborators

• Kaveh Aslani, MD: lead

Study Sites (1)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Tonsillitis; Airway Obstruction; Deglutition Disorders

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Respiration Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The number of participants in both groups are very small. Data in pain scores outcome was skewed.

Results Point of Contact

• Title: Kaveh Aslani, MD
• Organization: Beaumont Hsopital

kaveh.aslani@beaumont.org

248-898-1907

Study Officials

• Kaveh Aslani, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: November 5, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 8, 2017
• Results First Posted: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)