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Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients (IV APAP SF)

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ClinicalTrials.gov Identifier: NCT01394718
Recruitment Status : Completed
First Posted : July 14, 2011
Results First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: Intravenous Acetaminophen
Other: Placebo
Enrollment 67
Recruitment Details All children of ages 10-18 undergoing posterior spine fusion surgery for idiopathic or neuromuscular scoliosis between July 2011 and May 2014 were eligible for inclusion.
Pre-assignment Details 281 subjects were screened, 125 approached for consent/assent and 67 consented/assented. Of the initial 67 subjects, 1 was withdrawn by the clinical team, 1 patient's surgery was cancelled, 2 were withdrawn by the family, and 3 were deemed ineligible after consent were removed from the study.
Arm/Group Title Saline Placebo Intravenous Acetaminophen
Hide Arm/Group Description

Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.

Period Title: Overall Study
Started 30 30
Completed 28 29
Not Completed 2 1
Reason Not Completed
Met protocol-specific stopping criteria             2             1
Arm/Group Title Saline Placebo Intravenous Acetaminophen Total
Hide Arm/Group Description

Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.

Total of all reporting groups
Overall Number of Baseline Participants 28 29 57
Hide Baseline Analysis Population Description
Analysis population includes only those subjects who completed at least 24 hours of post-operative data collection. 3 subjects who were enrolled and received at least 1 dose were removed before reaching the 24 hour post-operative milestone.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 57 participants
14.43  (1.69) 14.17  (1.87) 14.30  (1.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
Female
19
  67.9%
25
  86.2%
44
  77.2%
Male
9
  32.1%
4
  13.8%
13
  22.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 29 participants 57 participants
28 29 57
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 28 participants 29 participants 57 participants
59.79  (13.69) 53.44  (11.32) 56.56  (12.83)
Surgery Duration  
Mean (Standard Deviation)
Unit of measure:  Hours (hr)
Number Analyzed 28 participants 29 participants 57 participants
5.21  (1.03) 5.09  (1.14) 5.15  (1.08)
Estimated Blood Loss (EBL)  
Median (Full Range)
Unit of measure:  Milliliter (ml)
Number Analyzed 28 participants 29 participants 57 participants
775
(450 to 2200)
600
(150 to 1400)
700
(150 to 2200)
Intra-operative methadone  
Median (Full Range)
Unit of measure:  Milligrams (mg)
Number Analyzed 28 participants 29 participants 57 participants
6.3
(0 to 10)
6.0
(0 to 10)
6.0
(0 to 10)
Intra-operative methadone  
Median (Full Range)
Unit of measure:  Milligrams/kilograms (mg/kg)
Number Analyzed 28 participants 29 participants 57 participants
0.1
(0 to 0.2)
0.1
(0 to 0.2)
0.1
(0 to 0.2)
1.Primary Outcome
Title Total Opiate Requirement
Hide Description Total opiate requirement was monitored 24 hours post-operatively. Morphine and hydromorphone measurements were totaled and recorded in mg/kg/day of morphine equivalents.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo.
Arm/Group Title Saline Placebo Intravenous Acetaminophen
Hide Arm/Group Description:

Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.

Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: mg/kg
1.19  (0.43) 1.01  (0.32)
2.Secondary Outcome
Title Average Pain Score
Hide Description Pain Scores were monitored using the numeric pain assessment scale in both treatment arms of the study and recorded and averaged for the first 24 hours after initial intra-operative dose of study drug. The numeric pain assessment scale is a verbal self-reported pain assessment that ranges between 1 (no pain) to 10 (worst pain imaginable).
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo
Arm/Group Title Saline Placebo Intravenous Acetaminophen
Hide Arm/Group Description:

Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.

Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.53  (2.02) 4.62  (1.99)
3.Secondary Outcome
Title Average Nausea Score
Hide Description Nausea scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Nausea Scores range from 1 (none) to 4 (severe).
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo
Arm/Group Title Saline Placebo Intravenous Acetaminophen
Hide Arm/Group Description:

Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.

Overall Number of Participants Analyzed 28 29
Median (Full Range)
Unit of Measure: units on a scale
1.2
(1.0 to 2.5)
1.0
(1.0 to 2.6)
4.Secondary Outcome
Title Average Pruritus Score
Hide Description Pruritus scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Pruritus scores range from 1 (none) to 3 (intolerable).
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo
Arm/Group Title Saline Placebo Intravenous Acetaminophen
Hide Arm/Group Description:

Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.

Overall Number of Participants Analyzed 28 29
Median (Full Range)
Unit of Measure: units on a scale
1.0
(1.0 to 2.5)
1
(1.0 to 2.0)
Time Frame 96 Hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Placebo Intravenous Acetaminophen
Hide Arm/Group Description

Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.

All-Cause Mortality
Saline Placebo Intravenous Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Saline Placebo Intravenous Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/29 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Placebo Intravenous Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/29 (0.00%) 
This is a single center study with subjects confined to a single surgical procedure with a small sample size, possibly limiting generalizability of results.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Athena Zuppa, MD, MSCE
Organization: Children's Hospital of Philadelphia
Phone: 267-426-7359
EMail: zuppa@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01394718    
Other Study ID Numbers: 11-08095
First Submitted: July 13, 2011
First Posted: July 14, 2011
Results First Submitted: March 17, 2016
Results First Posted: April 18, 2016
Last Update Posted: April 18, 2016