Phase 3 N=60 Randomized Quadruple-blind Prevention

Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia

Pain · Hyperalgesia · Inflammatory Response

Bottom Line

View on ClinicalTrials.gov: NCT01301079 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Pain 30 Minutes — 5.5; 6.2 units on a scale — p=0.386

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ketamine (Drug); Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Federal University of São Paulo
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain 30 Minutes	5.5; 6.2	0.386
PRIMARY Pain 60 Minutes	4.6; 5.1	0.499
PRIMARY Pain 90 Minutes	3.4; 3.4	0.909
PRIMARY Pain 120 Minutes	2.2; 2.0	0.737
PRIMARY Pain 150 Minutes	1.4; 1.4	<0.872
PRIMARY Pain 180 Minutes	1.1; 1.3	0.598
PRIMARY Pain 210 Minutes	0.9; 1.2	0.485
PRIMARY Pain 240 Minutes	1.0; 1.1	0.744
PRIMARY Pain 6 Hours	0.9; 0.7	0.540
PRIMARY Pain 12 Hours	1.6; 1.4	0.673
PRIMARY Pain 18 Hours	1.5; 1.3	0.586
PRIMARY Pain 24 Hours	1.4; 0.8	0.077
SECONDARY Time to First Morphine Supplementation	18; 15	0.113
SECONDARY Morphine Consumption Within 24 h	27.40; 27.70	0.946
SECONDARY Hyperalgesia in the Preoperative Period as Measured With Monofilaments in Thenar Eminence	300; 300	0.999
SECONDARY Hyperalgesia in the Postoperative Period as Measured With Monofilaments in Thenar Eminence	290; 247	0.019 sig
SECONDARY Hyperalgesia in the Preoperative Period as Measured With Monofilaments in the Periumbilical Region	279; 269	0.652
SECONDARY Hyperalgesia in the Postoperative Period as Measured With Monofilaments in the Periumbilical Region	248; 205	0.221
SECONDARY Hyperalgesia in the Preoperative Period as Measured With Algometer in Thenar Eminence	2.51; 2.19	0.325
SECONDARY Hyperalgesia in the Postoperative Period as Measured With Algometer in Thenar Eminence	0.56; 0.51	0.677
SECONDARY Hyperalgesia in the Preoperative Period as Measured With Algometer in the Periumbilical Region	3.6; 3.9	0.545
SECONDARY Hyperalgesia in the Postoperative Period as Measured With Algometer in the Periumbilical Region	3.5; 3.7	0.650
SECONDARY Extension of Hyperalgesia	10.61; 11.82	0.593
SECONDARY Allodynia as Detected With a Soft Brush in the Periumbilical Region Before the Procedure	1; 0	0.313
SECONDARY Allodynia as Detected With a Soft Brush in the Periumbilical Region 24 h After the Procedure	1; 0	0.313
SECONDARY Allodynia as Detected With a Soft Brush in the Thenar Eminence Before the Procedure	1; 0	0.313
SECONDARY Allodynia as Detected With a Soft Brush in the Thenar Eminence 24 h After the Procedure	1; 3	0.611
SECONDARY Serum Level of Interleukin (IL)-6 Before the Procedure	3.3; 2.1	0.312
SECONDARY Serum Level of Interleukin (IL)-6 5 h After the Procedure	29.3; 34.8	0.676
SECONDARY Serum Level of Interleukin (IL)-6 24 h After the Procedure	24.1; 24.8	0.938
SECONDARY Serum Level of Interleukin (IL)-8 Before the Procedure	3.3; 2.2	0.385
SECONDARY Serum Level of Interleukin (IL)-8 5 h After the Procedure	8.0; 11.3	0.422
SECONDARY Serum Level of Interleukin (IL)-8 24 h After the Procedure	6.0; 4.5	0.500
SECONDARY Serum Level of Interleukin (IL)-10 Before the Procedure	7.8; 1.9	0.435
SECONDARY Serum Level of Interleukin (IL)-10 5h After the Procedure	9.1; 5.5	0.745
SECONDARY Serum Level of Interleukin (IL)-10 24 h After the Procedure	8.6; 5.0	0.557

Summary

The aim of this study was to determine if the addition of ketamine reduces remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL(interleukin)-6 and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine).

Eligibility Criteria

Inclusion Criteria

≥ 18 years old
both sexes
ASA physical status I or II
undergoing laparoscopic cholecystectomy

Exclusion Criteria

chronic users of analgesics or had used opioids within 12 h of surgery
history of drug or alcohol abuse or psychiatric disorder
contraindications to self-administration of opioids (ie, unable to understand the patient-controlled analgesia [PCA] device)
contraindication for the use of ketamine, such as a psychiatric disorder, acute cardiovascular disorder, or unstable hypertension

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Data sourced from ClinicalTrials.gov (NCT01301079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.