Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Pain, Postoperative Clinical Trial

Official title:

Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487303
• Other study ID #: Pro00041193
• Status: Completed
• Phase: N/A
• Start date: March 17, 2015
• Est. completion date: July 27, 2017

Study information

• Verified date: November 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.

Description:

This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 27, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parturients 18 years

• Elective Cesarean delivery

• Spinal anesthesia

• Able to consent to the study and participate in the follow-up.

Exclusion Criteria:

• Weight under 50 kgs

• Allergy to acetaminophen

• General anesthesia

• Urgent or emergent cases

• Bleeding diathesis or other coagulopathy

• G6PD deficiency

• Liver disease

• Substance abuse or dependence

• HELLP syndrome

• Thrombocytopenia or platelet dysfunction

• History or active gastrointestinal bleeding

• Acute kidney injury or chronic renal insufficiency

• Contraindication/refusal to spinal anesthesia

• Chronic pain

• Chronic narcotic use

• Illicit drug use

• Allergy to any study related medications.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Acetaminophen Intravenous
IV 1 gram f3 doses over 24 hours
• Acetaminophen Oral
Oral 1 gram 3 doses over 24 hours

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (9)

Alhashemi JA, Alotaibi QA, Mashaat MS, Kaid TM, Mujallid RH, Kaki AM. Intravenous acetaminophen vs oral ibuprofen in combination with morphine PCIA after Cesarean delivery. Can J Anaesth. 2006 Dec;53(12):1200-6. — View Citation

Beatty NC, Arendt KW, Niesen AD, Wittwer ED, Jacob AK. Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine. J Clin Anesth. 2013 Aug;25(5):379-383. doi: 10.1016/j.jclinane.2013.01.014. Epub 2013 Aug 17. — View Citation

Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. do — View Citation

Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28. Review. — View Citation

Singh SI, Rehou S, Marmai KL, Jones PM. The efficacy of 2 doses of epidural morphine for postcesarean delivery analgesia: a randomized noninferiority trial. Anesth Analg. 2013 Sep;117(3):677-85. doi: 10.1213/ANE.0b013e31829cfd21. Epub 2013 Aug 6. — View Citation

Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32 — View Citation

Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011 Jun;12(6):961-81. doi: 10.1111/j.1526-4637.2011.01141.x. Epub 2011 May 31. Review. — View Citation

Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal lapa — View Citation

Wong JY, Carvalho B, Riley ET. Intrathecal morphine 100 and 200 µg for post-cesarean delivery analgesia: a trade-off between analgesic efficacy and side effects. Int J Obstet Anesth. 2013 Jan;22(1):36-41. doi: 10.1016/j.ijoa.2012.09.006. Epub 2012 Nov 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Postoperative Opiate Consumption	Cumulative opiate consumption (IV morphine equivalents)	24 hours
Secondary	Time to First Opiate Rescue	Time to first opiate pain medicine requested by patient	48 hours
Secondary	VAS (Visual Analog Scale)	Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) .	24 hours
Secondary	Time Discharge	Time patient meets discharge criteria will be recorded	24 hours postoperative