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Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery

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ClinicalTrials.gov Identifier: NCT02647788
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: Acetaminophen/Ibuprofen
Drug: Acetaminophen/Codeine
Enrollment 144
Recruitment Details All patients were recruited between 11/18/15 and 1/10/18 and were identified on the physicians surgery schedule as patients receiving either trigger finger or carpel tunnel surgery.
Pre-assignment Details There were 4 patients that were enrolled but did not make it to the randomization stage. 2 patients had liver disease and therefore met exclusion criteria for the study. The other 2 patients did not have surgery.
Arm/Group Title Acetaminophen/Ibuprofen Acetaminophen/Codeine
Hide Arm/Group Description

Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg

Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit

Group 2: Acetaminophen 300mg, Codeine 30 mg

Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

Period Title: Overall Study
Started 70 70
Completed 54 57
Not Completed 16 13
Reason Not Completed
Lost to Follow-up             13             11
Did not want opiate             0             1
Withdrawal by Subject             1             0
Felt itchy with assigned medication             1             0
Felt nauseous with assigned medication             1             1
Arm/Group Title Acetaminophen/Ibuprofen Acetaminophen/Codeine Total
Hide Arm/Group Description

Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg

Acetaminophen/Ibuprofen: After surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit

Group 2: Acetaminophen 300mg, Codeine 30 mg

Acetaminophen/Codeine: After surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

Total of all reporting groups
Overall Number of Baseline Participants 54 57 111
Hide Baseline Analysis Population Description
144 patients were consented for this study. There were 4 patients that were enrolled but did not make it to the randomization stage and 140 patients were placed into the study. 111 patients completed the study and were included in analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 57 participants 111 participants
60  (12) 59  (13) 59  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 57 participants 111 participants
Female
37
  68.5%
38
  66.7%
75
  67.6%
Male
17
  31.5%
19
  33.3%
36
  32.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 57 participants 111 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   7.4%
1
   1.8%
5
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
17
  31.5%
19
  33.3%
36
  32.4%
White
32
  59.3%
36
  63.2%
68
  61.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.9%
1
   1.8%
2
   1.8%
VAS Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 54 participants 57 participants 111 participants
1.93  (2.04) 2.50  (2.51) 2.22  (2.30)
[1]
Measure Description: The visual analog scale (VAS) for pain is a patient reported outcome measurement. It is a continuous scale anchored by no pain (0) and worst pain imaginable (10).
1.Primary Outcome
Title Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score
Hide Description To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable.
Time Frame Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores
Hide Outcome Measure Data
Hide Analysis Population Description
111 patients completed the study and their data was included in the analysis
Arm/Group Title Acetaminophen/Ibuprofen Acetaminophen/Codeine
Hide Arm/Group Description:

Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg

Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit

Group 2: Acetaminophen 300mg, Codeine 30 mg

Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

Overall Number of Participants Analyzed 54 57
Mean (Standard Deviation)
Unit of Measure: score on a scale
VAS Pain Day 1 Number Analyzed 49 participants 53 participants
2.90  (2.22) 3.51  (2.69)
VAS Pain Day 2 Number Analyzed 43 participants 47 participants
2.36  (2.31) 2.40  (2.52)
VAS Pain Day 3 Number Analyzed 37 participants 40 participants
1.69  (2.00) 2.26  (2.38)
VAS Pain Day 4 Number Analyzed 35 participants 35 participants
1.47  (1.82) 1.93  (2.01)
VAS Pain Day 5 Number Analyzed 30 participants 34 participants
1.23  (1.61) 1.48  (1.48)
VAS Pain Day 6 Number Analyzed 29 participants 30 participants
1.29  (1.49) 1.35  (1.37)
VAS Pain Day 7 Number Analyzed 23 participants 27 participants
1.17  (1.38) 1.01  (1.21)
2.Secondary Outcome
Title Quality of Recovery-9 (QoR-9).
Hide Description To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2.
Time Frame Postoperative Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 111 subjects that completed the study, QoR score was available for 93 participants.
Arm/Group Title Acetaminophen/Ibuprofen Acetaminophen/Codeine
Hide Arm/Group Description:

Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg

Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit

Group 2: Acetaminophen 300mg, Codeine 30 mg

Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

Overall Number of Participants Analyzed 44 49
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
16.91  (1.38) 16.65  (1.91)
3.Secondary Outcome
Title Number of Pills Used
Hide Description [Not Specified]
Time Frame From the time of surgery to first clinic visit (post-op day 6 to 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 111 subjects that completed the study, data about how many capsules were used was available for 100 participants.
Arm/Group Title Acetaminophen/Ibuprofen Acetaminophen/Codeine
Hide Arm/Group Description:

Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg

Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit

Group 2: Acetaminophen 300mg, Codeine 30 mg

Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: Pills
13.72  (8.04) 14.14  (9.77)
Time Frame Adverse events were collected for the subjects time participating on the study. Participation began on the subject's surgery day and ended at their first clinical visit (6-8 days after surgery).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen/Ibuprofen Acetaminophen/Codeine
Hide Arm/Group Description

Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg

Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit

Group 2: Acetaminophen 300mg, Codeine 30 mg

Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

All-Cause Mortality
Acetaminophen/Ibuprofen Acetaminophen/Codeine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen/Ibuprofen Acetaminophen/Codeine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Acetaminophen/Ibuprofen Acetaminophen/Codeine
Affected / at Risk (%) Affected / at Risk (%)
Total   32/70 (45.71%)   30/70 (42.86%) 
General disorders     
Nausea   8/70 (11.43%)  7/70 (10.00%) 
Constipation   8/70 (11.43%)  12/70 (17.14%) 
Itchiness   12/70 (17.14%)  11/70 (15.71%) 
Dizziness   3/70 (4.29%)  2/70 (2.86%) 
Drowsiness   22/70 (31.43%)  10/70 (14.29%) 
Indicates events were collected by systematic assessment
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: Dr. Benjamin Gray
Organization: University of Pennsylvania
Phone: 215-294-9650
EMail: Benjamin.Gray@uphs.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02647788     History of Changes
Other Study ID Numbers: BACH-2015, 823043
First Submitted: January 4, 2016
First Posted: January 6, 2016
Results First Submitted: January 18, 2019
Results First Posted: February 18, 2019
Last Update Posted: February 18, 2019