Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

This study has been completed.

Sponsor:

Information provided by:

Cadence Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00399568

First received: November 14, 2006

Last updated: December 9, 2010

Last verified: December 2010

History of Changes

Results First Received: September 25, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Postoperative Pain Hysterectomy
Interventions:	Drug: IV Acetaminophen Drug: IV Placebo 100 mL solution

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Gynecologists and/or anesthesiologists were selected to participate as Principal Investigators.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were required to meet eligibility criteria prior to surgery and then again had to meet post surgical inclusion criteria.Subjects had to achieve a sufficient pain intensity score prior to entering the study.

Reporting Groups

	Description
IV Acetaminophen 1 g/100 mL Solution	All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
IV Placebo 100 mL Solution	All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.

Participant Flow: Overall Study

	IV Acetaminophen 1 g/100 mL Solution	IV Placebo 100 mL Solution
STARTED	166	165
COMPLETED	154	156
NOT COMPLETED	12	9
Adverse Event	1	2
Withdrawal by Subject	7	3
Protocol non-compliance	2	2
Lost to Follow-up	2	2

Baseline Characteristics

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Reporting Groups

	Description
IV Acetaminophen 1 g/100 mL Solution	All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
IV Placebo 100 mL Solution	All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
Total	Total of all reporting groups

Baseline Measures

	IV Acetaminophen 1 g/100 mL Solution	IV Placebo 100 mL Solution	Total
Number of Participants [units: participants]	166	165	331
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	163	161	324
>=65 years	3	4	7
Gender [units: participants]
Female	166	165	331
Male	0	0	0
Region of Enrollment [units: participants]
United States	166	165	331

Outcome Measures

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1. Primary:

Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo. [ Time Frame: Baseline (just prior to the first dose) through 24 hours ]

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2. Primary:

Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo [ Time Frame: Baseline (just prior to the first dose) through 48 hours ]

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3. Secondary:

Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: First dose through 7 day follow up ]

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4. Secondary:

Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event. [ Time Frame: 32 days following first dose of study medication. ]

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Serious Adverse Events

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Other Adverse Events

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