Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain

Ankara University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Acute Pain

Treatments: Drug: Ibuprofen 800 mg; Drug: Paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT03063658

16-827-16

Details and patient eligibility

About

This study will evaluate two different analgesic regimen used for acute postoperative pain.

Full description

Laparoscopic cholecystectomy is a type of surgery that causes moderate postoperative pain. Paracetamol and non-steroid anti-inflammatory analgesics plus opioids are the mainstay treatment options of the moderate postoperative pain. These drugs are the most common used analgesics to ameliorate this type of pain and to reduce the consumption of opioids and their side effects.

Ibuprofen is a well-known anti-inflammatory drug and has been used as an oral formula for a long time. Few studies using its new intravenous formula had been conducted to evaluate its effectiveness for mixed type of surgeries . However, its intravenous formula has not been studied for laparoscopic cholecystectomy. Therefore, this study will compare the effects of postoperative analgesic potencies of preemptive intravenous paracetamol and ibuprofen in patients undergoing laparoscopic cholecystectomy.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. American Society of Anesthesiologist Functional Status 1-2
2. Body mass index smaller than 30
3. Undergoing laparoscopic cholecystectomy
4. Age between 18-60 years

Exclusion criteria

1. Age under 18, above 60
2. Weight under 40 kg
3. Body mass index above 30
4. Contraindication for opioid and non-steroid anti-inflammatory drug usage
5. Allergy against paracetamol, opioids and anti-inflammatory drugs
6. Peptic ulcer
7. Tendency to bleeding
8. Pregnancy or breast feeding
9. Moderate or severe renal, hepatic or cardiac insufficiency
10. Coronary artery disease
11. Asthma

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups

Paracetamol

Active Comparator group

Description:

Paracetamol (Paracerol) 1 gram will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.

Treatment:

Drug: Paracetamol

Ibuprofen

Active Comparator group

Description:

Ibuprofen (Intrafen) 800 mg will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.

Treatment:

Drug: Ibuprofen 800 mg