Trial Outcomes & Findings for Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section (NCT NCT03372382)

Results Overview

pain level measured by objective and subjective scales. 1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean "less pain" and a point towards the right will mean "more pain". After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

170 participants

Primary outcome timeframe

2-4 weeks postpartum

Results posted on

2019-07-02

Participant Flow

recruitment start date: 12/2017 recruitment end date: 03/2018

Participant milestones

Participant milestones
Measure	Ibuprofen Plus Acetaminophen women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Ibuprofen: NSAID Acetaminophen: analgesic 85 women recruited into this study arm	Ibuprofen Plus Acetaminophen/Hydrocodone women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone Ibuprofen: NSAID Acetaminophen plus hydrocodone: Opioid 85 women recruited into this study arm
Overall Study STARTED	85	85
Overall Study COMPLETED	76	81
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibuprofen Plus Acetaminophen n=85 Participants women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Ibuprofen: NSAID Acetaminophen: analgesic 85 women recruited into this study arm	Ibuprofen Plus Acetaminophen/Hydrocodone n=85 Participants women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone Ibuprofen: NSAID Acetaminophen plus hydrocodone: Opioid 85 women recruited into this study arm	Total n=170 Participants Total of all reporting groups
Age, Continuous	28.39 years STANDARD_DEVIATION 5.8 • n=5 Participants	28.05 years STANDARD_DEVIATION 5.64 • n=7 Participants	28.2 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	85 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · African american	36 Participants n=5 Participants	49 Participants n=7 Participants	85 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Race/Ethnicity, Customized Race · white	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race · other	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-4 weeks postpartum

Population: The primary outcome was available in 71 patients in the non-opioid group and 76 patients in the opioid group. The results below are primary outcome data analyzed by intention to treat.

pain level measured by objective and subjective scales. 1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean "less pain" and a point towards the right will mean "more pain". After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain.

Outcome measures

Outcome measures
Measure	Ibuprofen Plus Acetaminophen n=71 Participants women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Ibuprofen: NSAID Acetaminophen: analgesic	Ibuprofen Plus Acetaminophen/Hydrocodone n=76 Participants women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco) Ibuprofen: NSAID Norco: acetaminophen plus opioid
Pain Level	12.3 millimeters on a scale Standard Deviation 19.5	15.9 millimeters on a scale Standard Deviation 20.4

SECONDARY outcome

Timeframe: 2-4 weeks postpartum

patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied)

Outcome measures

Outcome measures
Measure	Ibuprofen Plus Acetaminophen n=76 Participants women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Ibuprofen: NSAID Acetaminophen: analgesic	Ibuprofen Plus Acetaminophen/Hydrocodone n=81 Participants women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco) Ibuprofen: NSAID Norco: acetaminophen plus opioid
Patient Satisfaction 1(very dissatisfied)	2 Participants	4 Participants
Patient Satisfaction 2(somewhat dissatisfied)	3 Participants	3 Participants
Patient Satisfaction 3(neutral)	11 Participants	12 Participants
Patient Satisfaction 4(satisfied)	23 Participants	16 Participants
Patient Satisfaction 5(very satisfied)	37 Participants	46 Participants

Adverse Events

Ibuprofen Plus Acetaminophen

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Ibuprofen Plus Acetaminophen/Hydrocodone

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ibuprofen Plus Acetaminophen n=85 participants at risk women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Ibuprofen: NSAID Acetaminophen: analgesic 85 women recruited into this study arm	Ibuprofen Plus Acetaminophen/Hydrocodone n=85 participants at risk women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone Ibuprofen: NSAID Acetaminophen plus hydrocodone: Opioid 85 women recruited into this study arm
Gastrointestinal disorders nausea / emesis	2.4% 2/85 • Number of events 2 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event	4.7% 4/85 • Number of events 5 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event
Gastrointestinal disorders constipation	8.2% 7/85 • Number of events 7 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event	15.3% 13/85 • Number of events 13 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event
General disorders somnolence	4.7% 4/85 • Number of events 4 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event	15.3% 13/85 • Number of events 13 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event
Gastrointestinal disorders GERD	1.2% 1/85 • Number of events 1 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event	2.4% 2/85 • Number of events 2 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event
General disorders itching	1.2% 1/85 • Number of events 1 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event	2.4% 2/85 • Number of events 2 • four months a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up. Medical records were also reviewed to determine if a patient had an adverse event

Additional Information

Dr Jenifer Dinis, MD

McGovern Medical School, University of Texas, Health Science Center at Houston

Phone: 713 500 6421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place